Digital Therapeutics Evaluation Framework & Pilot Implementation in Poland

Executive Summary

This policy paper presents a comprehensive framework for evaluating and implementing Digital Therapeutics (DTx) for addiction treatment in Poland, with potential applicability to other healthcare systems. DTx represent evidence-based software interventions that can help address the significant treatment gap for substance use disorders (SUDs) in Poland, where approximately 600,000 individuals accessed healthcare for alcohol-related disorders in 2022, with many more affected by various substance dependencies.

The proposed evaluation framework establishes rigorous standards across four key domains:

1. Clinical Effectiveness: A risk-stratified approach requiring randomized controlled trials and real-world evidence proportionate to the DTx's claimed benefits and potential risks. High-risk applications require multiple RCTs with active comparators and 12-month follow-up data, while lower-risk applications have appropriately scaled requirements.
2. Technical and Security Standards: Mandates interoperability with Poland's P1 Platform, compliance with EU Medical Device Regulation, robust data protection measures exceeding GDPR minimums for sensitive addiction data, and transparency in algorithmic decision-making.
3. User Experience and Engagement: Requires evidence of meaningful engagement with therapeutic components, cultural adaptation for Polish populations, and design considerations for varying levels of digital literacy to ensure equitable access.
4. Integration with Care Models: Emphasizes DTx as complements to, not replacements for, existing evidence-based treatments, with particular attention to supporting medication-assisted treatment where appropriate.

The paper recommends a three-phase pilot implementation strategy focusing initially on alcohol use disorder:

• Phase 1 (Months 1-6): Establish a multi-stakeholder evaluation committee, define criteria, and select 2-3 DTx products
• Phase 2 (Months 7-18): Deploy selected DTx in 8-12 treatment centers with 800-1,200 patients, collecting comprehensive real-world data
• Phase 3 (Months 19-24): Analyze outcomes, refine the evaluation framework, and develop recommendations for scaling and reimbursement

For sustainable implementation, the paper proposes several reimbursement models, including value-based reimbursement tied to outcomes, subscription models, and hybrid funding approaches. It emphasizes the importance of stakeholder engagement—particularly healthcare providers, patients, and payers—and capacity building through knowledge hubs, workforce training, and public awareness campaigns.

The policy recommendations acknowledge potential limitations and risks of DTx, including digital divide concerns, data privacy, and the need to maintain human connection in addiction treatment. They call for balanced regulatory approaches that foster innovation while protecting patients, clear reimbursement pathways, and cross-border recognition to accelerate access to effective solutions.

By implementing this framework, Poland can leverage DTx to expand access to evidence-based addiction treatment while ensuring these digital interventions meet high standards for safety, efficacy, equity, and integration with existing care systems.

Digital Therapeutics Evaluation Framework & Pilot Implementation in Poland

Background and Context

Digital Therapeutics (DTx) represent an emerging category of medical interventions delivered through software programs to prevent, manage, or treat medical disorders or diseases (Psychiatric Times, 2021; Digital Therapeutics Alliance, 2021). These interventions are distinct from general wellness applications as they deliver evidence-based therapeutic content and processes, often mirroring or augmenting established clinical practices. Crucially, DTx are subject to regulatory oversight to ensure safety, efficacy, and quality (Psychiatric Times, 2021; Gordon & Spiegel, 2020). DTx products typically undergo rigorous clinical testing and validation, similar to traditional medical treatments, before they can be prescribed or recommended by healthcare professionals (Bates et al., 2021).

Poland, with its progressively developing digital health ecosystem, presents a unique and timely opportunity for the strategic implementation of DTx in addiction treatment. The nation faces a concerning burden of substance use disorders (SUDs). While precise prevalence figures vary by methodology, national reports and international bodies highlight significant challenges. The World Health Organization (WHO) (2018) data indicated that approximately 3.5% of the Polish population aged 15+ had an alcohol use disorder in the past year. More recent national data from the National Health Fund of Poland (NFZ) showed that in 2022, over 600,000 individuals accessed healthcare services due to alcohol-related disorders, though this reflects treated prevalence rather than overall population prevalence (NFZ, 2023). Beyond alcohol, Poland also experiences challenges with other substance dependencies, including increasing concerns regarding the use of stimulants and new psychoactive substances (EMCDDA, 2023).

This situation is exacerbated by traditional treatment approaches often being hampered by accessibility barriers, particularly in rural and underserved regions, pervasive social stigma associated with seeking help for addiction, and an insufficient number of specialized healthcare professionals (Moskalewicz & Sierosławski, 2024; Jabłoński & Rączka, 2017). Consequently, a significant treatment gap exists. While specific figures for Poland vary, European data suggests that a large majority of individuals with SUDs do not receive formal treatment (EMCDDA, 2022). This underscores the urgent need for innovative solutions like DTx to expand access and improve outcomes. The Polish drug treatment system is integrated within the broader mental health care framework and is governed by specific national laws, which will be a key consideration for DTx integration (Jabłoński & Rączka, 2017). The COVID-19 pandemic further highlighted the need for remote and digitally-enabled care options, accelerating discussions around digital health adoption globally and in Poland (Polish Ministry of Health, 2022).

Substance Use Disorder (SUD) is defined as a mental health condition characterized by a problematic pattern of substance use leading to impairment or distress (American Psychiatric Association, 2022). Effective treatment often involves a combination of pharmacological and behavioral interventions. Medications for Opioid Use Disorder (MOUD), such as methadone, buprenorphine, and naltrexone, are FDA-approved in the US and recommended by global health bodies, having demonstrated significant efficacy in improving outcomes (CDC, 2024; WHO, 2020). Similarly, nicotine replacement therapies and medications like varenicline are common for treating nicotine addiction (NIDA, 2022). DTx can complement these approaches by delivering evidence-based behavioral therapies (e.g., Cognitive Behavioral Therapy, Motivational Interviewing), monitoring, and support. For instance, DTx interventions have shown effectiveness in treating various SUDs, including nicotine, alcohol, and opioid use disorders (Marsch et al., 2022; Cheung et al., 2023). Specific DTx products like reSET® and reSET-O®, which deliver prescription cognitive behavioral therapy for SUD and OUD respectively, have received regulatory clearance in the United States and have demonstrated improved outcomes in clinical trials when used as adjuncts to standard care (Christensen et al., 2019; Maricich et al., 2021). Another example is 'Quit Genius', a DTx for smoking cessation and other SUDs, which has shown positive results in real-world studies (Kurti et al., 2021).

Global DTx Landscape

The international landscape offers several established models for the evaluation and reimbursement of digital health applications, providing valuable precedents for Poland. Germany's Digital Healthcare Act (Digitale-Versorgung-Gesetz, DVG), enacted in 2019, created a "fast-track" pathway for Digitale Gesundheitsanwendungen (DiGA) or "apps on prescription" (Gerke et al., 2020). Doctors and psychotherapists can prescribe DTx approved by the Federal Institute for Drugs and Medical Devices (BfArM) based on safety, functionality, quality, data security, interoperability, and evidence of a "positive healthcare effect." DiGAs can be provisionally listed for reimbursement for 12-24 months while developers gather further real-world evidence or conduct trials to demonstrate these positive care effects (BfArM, 2023). An example of an addiction-focused DiGA is somnio, which addresses insomnia, a condition often comorbid with SUDs, though DiGAs specifically targeting SUDs like alcohol use disorder (e.g., Vorvida) are also available (BfArM DiGA Verzeichnis, 2024).

The United Kingdom has developed a comprehensive approach through the National Institute for Health and Care Excellence (NICE), which provides an Evidence Standards Framework for Digital Health Technologies (DHTs) (NICE, 2022). This framework helps developers and commissioners understand the level of evidence required for adoption within the National Health Service (NHS), tiered by the technology's function and potential risk, focusing on clinical and cost-effectiveness. This tiered approach could be particularly valuable for Poland, allowing for appropriate scrutiny based on the risk profile of different addiction-focused DTx solutions.

France has implemented the PECAN (Prise En Charge Anticipée Numérique) program for early reimbursement of innovative digital medical devices, including DTx, that demonstrate potential clinical benefit, even before full CE marking under MDR if under clinical investigation (Haute Autorité de Santé, 2021). This approach recognizes the rapid pace of digital innovation and could be adapted to accelerate access to promising addiction treatment technologies in Poland.

Belgium's mHealthBelgium platform uses a three-tiered validation pyramid where applications reaching the top tier (M3) are validated for clinical reliability and data security, making them eligible for potential reimbursement (mHealthBelgium, 2023). This graduated approach provides clarity to developers and ensures appropriate scrutiny based on intended use and risk profile.

The United States offers important lessons through its regulatory pathways for clearing or approving DTx, including Prescription Digital Therapeutics (PDTs) (FDA, 2023). However, the reimbursement landscape is fragmented. While some states have made progress in integrating digital health into public services (SAMHSA, 2022), consistent reimbursement, especially through Medicaid, remains a significant challenge, often hindering widespread adoption despite recognized needs, for example, in youth behavioral health services (ASPE HHS, 2023; AcademyHealth, 2022). This highlights the importance of developing clear reimbursement mechanisms alongside regulatory pathways in Poland.

These international frameworks emphasize the importance of clear regulatory pathways, robust evidence requirements (including real-world evidence), and structured reimbursement mechanisms, offering valuable lessons for Poland's approach to addiction-focused DTx.

Polish Digital Health Readiness

Poland has made commendable progress in establishing a foundational digital health infrastructure. Key developments include the P1 Platform (e-Zdrowie), facilitating nationwide e-prescriptions, e-referrals, and the Internet Patient Account (IKP) (Centrum e-Zdrowia, 2023). Smartphone penetration is high, with recent estimates around 90% in 2023 (GUS, 2023), and internet accessibility continues to improve. These factors suggest strong societal readiness for digital health solutions that could transform addiction treatment delivery.

However, a structured national evaluation framework specifically for addiction-focused DTx is currently absent. The existing Polish drug treatment system, while part of the broader mental health care system, has distinct therapeutic traditions and involves various professional groups, often with separate paths for medical and psychosocial approaches (Moskalewicz & Sierosławski, 2024). Any DTx evaluation framework must be sensitive to these structures to ensure successful integration and avoid reinforcing existing silos in care delivery.

Several barriers specific to addiction treatment in Poland need consideration when developing policy for DTx implementation. Privacy concerns and stigma remain significant challenges, as addiction continues to be highly stigmatized, and concerns about data privacy and confidentiality of sensitive health information stored in digital platforms could deter use (Ali et al., 2021). Policy frameworks must prioritize robust privacy protections and confidentiality measures to address these legitimate concerns.

Digital literacy and access present another policy challenge. While smartphone penetration is high, disparities in digital literacy and access to reliable internet or suitable devices may exist among vulnerable populations with SUDs and older healthcare providers (Schrader et al., 2022). Effective policy must include provisions for digital literacy training and potentially subsidized access to ensure equitable implementation.

Cultural attitudes toward technology-based interventions for conditions traditionally managed with intensive interpersonal therapy may present resistance from both patients and providers (Torous & Roberts, 2021). Policy approaches should acknowledge these concerns and emphasize the complementary rather than replacement role of DTx in comprehensive addiction treatment.

Integration with existing systems presents complex policy considerations. Integrating DTx into the often bifurcated mental health and addiction service pathways, and ensuring interoperability with systems like P1, will require thoughtful policy development (Moskalewicz & Sierosławski, 2024). Standards for interoperability and data exchange should be central to any DTx evaluation framework.

Provider training and acceptance will be critical success factors. Healthcare professionals will require training and support to confidently prescribe, recommend, and integrate DTx into their workflows (Keenan et al., 2022). Policy should mandate appropriate training requirements and potentially incentivize adoption through reimbursement mechanisms.

The potential cost-effectiveness of DTx for SUDs is a significant driver for adoption, with studies suggesting they can reduce healthcare utilization and improve outcomes compared to standard care, though more research specific to the Polish context is needed (Leurent et al., 2018; Gentry et al., 2019). Policy frameworks should incorporate health technology assessment methodologies that appropriately value both direct and indirect benefits of DTx interventions.

Patient perspectives are also crucial for policy development; research indicates that many individuals with SUDs are willing to use digital tools, particularly if they are user-friendly, confidential, and offer tangible benefits like improved coping skills or relapse prevention (Kay-Lambkin et al., 2019; Tait et al., 2020). Policies should encourage user-centered design and potentially require evidence of user engagement and satisfaction as part of evaluation criteria.

Integration with Existing Treatment Approaches

DTx should not be seen as a replacement for traditional care but as a complement within comprehensive addiction policy. They can extend the reach of services to remote or underserved areas, addressing a key policy goal of improving treatment access. They can provide support between therapy sessions or post-discharge, potentially reducing relapse rates and improving continuity of care. DTx can deliver standardized, evidence-based interventions consistently, supporting policy objectives around quality improvement and standardization of care.

The potential anonymity offered by DTx could reduce barriers for those hesitant to seek face-to-face help due to stigma, addressing a persistent policy challenge in addiction treatment. Furthermore, DTx can support integrated care models by facilitating communication and data sharing (with patient consent) between different providers involved in a patient's care, potentially bridging gaps between medical and psychosocial services (Moskalewicz & Sierosławski, 2024). This integration capability should be a key consideration in policy development.

While promising, DTx for addiction are not without limitations that must be acknowledged in policy development. The evidence base, while growing, needs further strengthening for long-term effectiveness and for specific SUD subtypes or populations (Riper et al., 2021; Kaner et al., 2017). Many studies focus on short-to-medium term outcomes. Policy frameworks should encourage ongoing research and potentially implement staged approval processes that allow provisional access while gathering additional evidence.

Engagement and adherence present ongoing challenges, as maintaining user engagement with DTx over time can be difficult, similar to adherence issues in traditional therapies (Torous et al., 2020). Policy approaches should consider requiring evidence of sustained engagement strategies and potentially linking reimbursement to demonstrated user engagement.

The therapeutic alliance remains a central concern, as over-reliance on technology could diminish the crucial human element of the therapeutic relationship, which is vital in addiction treatment (Baumel et al., 2020). Policy should promote blended care models where DTx supports, rather than replaces, human interaction, potentially through specific reimbursement mechanisms for combined human-digital interventions.

Resistance from providers may impede implementation, as some traditional providers may be hesitant to adopt DTx due to unfamiliarity, concerns about efficacy, workflow disruption, or perceived depersonalization of care (Hollis et al., 2022). Policy approaches should include provider education, training, and incentives to demonstrate clear value and facilitate adoption.

Equity and digital divide issues must be central to policy development. DTx implementation must address potential equity issues, as disparities in access to technology, digital literacy, and culturally appropriate content could exacerbate existing health inequalities if not proactively managed (Crawford & Serhal, 2020). Policy solutions should include provisions for subsidized devices/data, offering multilingual support, and requiring co-design of DTx with diverse user groups.

The development of a Polish-specific DTx evaluation framework for SUDs is crucial for advancing addiction policy. It must ensure safety, effectiveness, and seamless integration into care pathways, considering the unique aspects of the Polish healthcare system, the impact of recent events like the COVID-19 pandemic on digital health adoption (Polish Ministry of Health, 2022), and the specific needs of individuals with addiction. Such a framework would help bridge the treatment gap and improve outcomes for this vulnerable population, representing a significant advancement in Polish addiction policy.

Proposed Evaluation Framework for Digital Therapeutics in Addiction Treatment

Clinical Effectiveness Criteria

Digital therapeutics (DTx) for addiction treatment require robust clinical effectiveness validation through multiple evidence pathways. This framework establishes clear standards while promoting innovation, ensuring interventions are safe, effective, and responsive to diverse patient populations' needs (Mohr et al., 2017).

Evidence Requirements Based on Current Research

Randomized Controlled Trials (RCTs) remain the gold standard for evaluating DTx effectiveness in addiction treatment. These interventions require rigorous clinical validation through controlled trials with clearly defined primary and secondary endpoints (Torous & Roberts, 2017). Appropriate endpoints should encompass abstinence rates measured through validated self-reporting with biological verification where feasible, reduction in substance use frequency and quantity, decreased craving intensity using validated scales, improvements in psychosocial functioning and mental health outcomes, and enhancements in treatment engagement and retention (NIDA, 2018; Marsden et al., 2017; Tiffany et al., 2012; World Health Organization, 1996; Campbell et al., 2014).

Meta-analyses of telepsychological services for substance use disorders (SUDs), including those in criminal justice populations, demonstrate moderate to large effect sizes, supporting digital interventions' efficacy even in complex populations (Campbell et al., 2014; Tofighi et al., 2022). Evidence should be differentiated based on the primary substance of abuse, as treatment efficacy varies significantly across substances (NIDA, 2020).

Real-World Evidence (RWE) studies complement RCTs by capturing effectiveness in naturalistic settings where adherence, engagement, and patient diversity often differ significantly from controlled trials (FDA, 2018; Sherman et al., 2016). A notable study evaluating a prescription digital therapeutic for SUD with 602 patients demonstrated significant real-world outcomes in treatment retention and abstinence rates, highlighting RWE's importance in complementing RCT data for addiction DTx (Xiong et al., 2022). These studies should clearly define patient populations, interventions, comparators, and outcomes while employing robust analytical methods to minimize bias (FDA, 2023).

DTx products should also demonstrate comparative effectiveness against, or added value to, standard care treatments. The National Institute on Drug Abuse emphasizes that new treatment modalities, including digital ones, should be evaluated against or in conjunction with established evidence-based behavioral therapies such as cognitive-behavioral therapy, contingency management, and motivational enhancement therapy (NIDA, 2020). Studies should assess whether DTx can improve outcomes, reduce costs, or increase access compared to existing treatments (Sullivan & O'Donoghue, 2019).

Given addiction's chronic, relapsing nature, the framework must require evidence of sustained effects beyond the acute treatment phase. With relapse rates for SUDs estimated between 40% and 60%, similar to other chronic illnesses like hypertension or asthma (McLellan et al., 2000; NIDA, 2020), DTx interventions should demonstrate effectiveness in supporting long-term recovery and relapse prevention, with follow-up data ideally extending to at least 12 months post-intervention (McKay, 2009). Specific relapse prevention features within the DTx should be evaluated for their impact on sustained outcomes (Marsch et al., 2014).

All submitted evidence should be assessed for quality using established frameworks such as GRADE for RCTs and STROBE for observational studies (Guyatt et al., 2008; von Elm et al., 2008), ensuring transparency and consistency in evaluating the strength of evidence supporting a DTx.

Risk-Stratified Evidence Requirements

The level of evidence required should be proportionate to the risk classification of the DTx product. High-risk applications, such as standalone treatments for severe addiction or DTx making strong therapeutic claims without clinician oversight, should provide multiple RCTs, including at least one with an active evidence-based comparator, and minimum 12-month follow-up data. Robust RWE demonstrating safety and effectiveness in diverse populations is also crucial for these applications (Halamka & Gips, 2021).

Medium-risk applications, including adjunctive treatments to standard care or tools for managing less severe SUDs under clinician guidance, should provide at least one well-designed RCT against a control or demonstrating superiority/non-inferiority to an existing intervention, with at least 6-month follow-up. Supporting RWE is encouraged for these applications (FDA, 2019).

Low-risk applications such as educational tools, symptom trackers, or recovery support platforms not making therapeutic claims should provide observational studies with validated outcome measures, usability testing, and evidence of user engagement and satisfaction. RWE demonstrating utility and safety is appropriate for these lower-risk interventions (Powell et al., 2017).

This risk-stratified approach aligns with international best practices in medical device and digital health regulation (International Medical Device Regulators Forum, 2017; NICE, 2022).

Technical and Security Standards

Technical Requirements

Interoperability is crucial for integrating DTx into existing healthcare ecosystems, enabling seamless data exchange and coordinated care (Adler-Milstein & Jha, 2017). Implementation of HL7® Fast Healthcare Interoperability Resources® (FHIR®) standards facilitates data exchange between digital therapeutics and electronic health records (CMS, 2020). For Poland specifically, DTx products must demonstrate compatibility with the P1 Platform (Platforma P1), Poland's national e-health system, which centralizes electronic medical records, e-prescriptions, and e-referrals (Centrum e-Zdrowia, 2023).

In addiction treatment settings, effective interoperability enables coordination between digital and in-person care providers, integration with medication-assisted treatment records and prescribing systems, continuity of care across different treatment settings, and comprehensive monitoring of recovery progress by authorized clinicians (Onders et al., 2018; NIDA, 2021; Grol et al., 2007; Marsch & Lord, 2012).

DTx products classified as medical devices must comply with relevant regulations, such as the European Union Medical Device Regulation (MDR 2017/745), which establishes stringent safety and performance requirements (European Commission, 2017). For addiction treatment applications, this includes clinical evaluation requirements proportionate to risk classification, robust post-market surveillance systems, unique device identification for traceability, and comprehensive technical documentation demonstrating safety, performance, and conformity with general safety and performance requirements.

Security and Privacy Standards

The General Data Protection Regulation has significant implications for addiction treatment technologies, as substance use information is considered "special category data" requiring heightened protection (European Union, 2016, Article 9). Strong measures must be implemented against unauthorized access or misuse of sensitive health data (European Data Protection Board, 2020).

For addiction DTx, GDPR compliance must address lawful basis for processing special category data, clear consent mechanisms, data minimization principles, data subject rights, and requirements for Data Protection Impact Assessments for high-risk processing activities common in sensitive health applications (European Union, 2016; Information Commissioner's Office, 2021).

DTx for addiction must implement robust security measures including end-to-end encryption for all data in transit and at rest, strong multi-factor authentication, regular independent penetration testing, secure storage of recovery and substance use data, and comprehensive incident response protocols (NIST, 2019; NIST, 2017; OWASP, 2021; ISO/IEC 27001, 2022; ENISA, 2020). These requirements align with international security standards and regulations like HIPAA in the U.S., which mandate safeguards for protected health information, including addiction treatment records (HHS, 2013).

The framework must clearly define patient rights regarding data ownership and control. Patients should receive transparent information about how their data will be used, including for research or product improvement (Nebeker et al., 2019). Mechanisms for patients to access, download, and request deletion of their data must exceed GDPR minimums where ethically appropriate for addiction data (Grande et al., 2019). Policies regarding de-identification and secondary use of data must be explicit, with opt-in consent preferred for uses beyond direct care or legally mandated reporting (Price & Cohen, 2019).

Where DTx employ algorithms for risk assessment, treatment personalization, or behavioral nudges, transparency regarding how these algorithms work, the data they use, and their potential biases is essential (Char et al., 2020). Developers should provide clear explanations understandable to clinicians and patients, and establish processes for validating algorithmic fairness and accuracy across different demographic groups (Leslie, 2019).

User Experience (UX) and Engagement Metrics

Evidence-Based Engagement Standards

Engagement is particularly critical for addiction DTx, as treatment outcomes often correlate with consistent and meaningful participation (Gustafson et al., 2014). Research indicates that sustained engagement with digital therapeutics links directly to better clinical outcomes (Xiong et al., 2022; Mohr et al., 2017). The framework should establish minimum engagement metrics based not just on usage, but on meaningful interaction with core therapeutic components, such as frequency and consistency of interactions with therapeutic modules, depth of engagement, demonstrable application of learned skills, and correlation between specific engagement patterns and clinical outcomes (Christensen et al., 2009; Perski et al., 2017; Yardley et al., 2016; Baumel et al., 2019).

Attrition rates for traditional addiction treatments can be high, often ranging from 30-60% within the first few months (Brorson et al., 2013; Stark, 1992). DTx products should aim to demonstrate retention rates that are comparable to or better than those of established in-person interventions for similar populations and severities. Benchmarks should consider severity of addiction being treated, patient population characteristics, treatment setting, and comparison to regional or national averages for traditional treatment retention (MATCH Project Research Group, 1997; Huhn et al., 2019; Ashford et al., 2019; SAMHSA, 2021).

Patient-reported experience measures and user satisfaction metrics should be standardized where possible to enable comparison and continuous improvement. Key metrics include perceived helpfulness in managing addiction, ease of use and accessibility, cultural appropriateness of content, perceived impact on therapeutic alliance if used in blended care, likelihood to recommend to others with similar conditions, and patient-centered outcome measures focusing on personal recovery goals (Schroder et al., 2017; Brooke, 1996; Barrera et al., 2013; Berger, 2017; Reichheld, 2003; Laudet, 2011).

Cultural Adaptation Requirements

DTx products must demonstrate cultural appropriateness for Polish populations, moving beyond simple translation to genuine cultural adaptation (Nápoles & Stewart, 2018). This includes language localization that considers dialects and culturally sensitive terminology, adaptation of therapeutic content to reflect Polish cultural contexts and social norms, consideration of local substance use patterns and societal views on addiction, alignment with Polish healthcare delivery models, and accommodation of regional variations within Poland (Temple & Young, 2004; Bernal & Domenech Rodríguez, 2012; Moskalewicz & Simmat-Durand, 2018; Kowalska-Bobko et al., 2020; PGR, 2021). Research consistently shows that culturally adapted digital interventions achieve better engagement and outcomes in behavioral health (Forehand & Kotchick, 1996; Rathod et al., 2018).

Digital Literacy and Equity Considerations

The framework must require DTx developers to accommodate varying levels of digital literacy and address potential equity issues, particularly important in addiction treatment where socioeconomic factors can impact technology access and familiarity (Latulippe et al., 2017; Hargittai, 2002). Requirements should include readability assessments for all text content, intuitive user interface design, provision of alternative access methods for users with limited technology skills or disabilities, availability of clear support resources, offline functionality for core therapeutic content in areas with limited internet connectivity, and proactive strategies to ensure equitable access across different socioeconomic and demographic groups (Wallace & Lennon, 2004; Nielsen, 2012; W3C, 2018; Bastien, 2010; Tomlinson et al., 2013; Veinot et al., 2018).

Ethical Considerations in Digital Addiction Treatment

The use of DTx in addiction treatment raises specific ethical challenges that must be proactively addressed. Informed consent processes must be clear, comprehensive, and ongoing, ensuring users understand the DTx's purpose, data usage, potential risks, benefits, limitations, and alternatives (Appelbaum & Lichtblau, 2021). Special attention is needed for vulnerable individuals who may feel pressured to use DTx (Roberts et al., 2019).

Addiction remains highly stigmatized in many societies. DTx must ensure utmost privacy to prevent accidental disclosure or data breaches that could lead to discrimination or harm (Fairchild & Bayer, 2004). Design choices should prioritize user discretion and confidentiality at every level.

Individuals with SUDs may be particularly vulnerable due to cognitive impairment, co-occurring mental health conditions, or socioeconomic instability. The framework must ensure DTx do not exploit these vulnerabilities and are designed to be supportive and empowering rather than controlling (Hendl et al., 2021).

In contexts like criminal justice or mandated treatment, the framework must guard against coercive use of DTx, ensuring genuine consent and the right to refuse digital treatment without penalty where appropriate (Reddy et al., 2019). Beyond digital literacy, the framework must consider affordability, device availability, and data plan costs, ensuring DTx do not exacerbate existing health disparities (Crawford & Serhal, 2020).

Integration with Existing Care Models

Effective DTx should complement and integrate with broader addiction treatment ecosystems. For SUDs where medication-assisted treatment is the standard of care, such as opioid use disorder, DTx should be designed to support MAT adherence, provide education, and facilitate communication with MAT prescribers (NIDA, 2021). Interoperability with e-prescribing and MAT monitoring systems is essential for comprehensive care.

If DTx incorporate contingency management principles, such as rewards for abstinence or engagement, these features must be evidence-based, ethically sound, and comply with relevant regulations regarding incentives in healthcare (Petry, 2011; DeFulio & Silverman, 2012). Transparency about reward mechanisms and their value is essential for both patients and providers.

Many individuals with SUDs also have co-occurring mental health disorders. DTx should either be designed to address common comorbidities such as depression and anxiety or effectively integrate with services that do (Drake & Mueser, 2002). Evidence for effectiveness in dually diagnosed populations should be provided as part of the evaluation process.

International Policy Comparisons

The U.S. Food and Drug Administration regulates digital health technologies, including some DTx, as Software as a Medical Device (FDA, 2021). The FDA's approach emphasizes a risk-based framework, premarket review for higher-risk devices, and post-market surveillance (FDA, 2019). The FDA's Digital Health Center of Excellence aims to advance digital health technology development and oversight, while their Real-World Evidence Framework details how RWE can support regulatory decisions, which is highly relevant for DTx (FDA, 2018).

Germany's Digital Healthcare Act established the "DiGA" framework, allowing physicians to prescribe approved digital health applications, including those for addiction (BfArM, 2023). Key elements include a fast-track approval process for DiGAs to be provisionally listed and reimbursed by statutory health insurance, contingent on demonstrating safety, data protection, and interoperability. DiGAs must demonstrate "positive healthcare effects" within a 12-month trial period to achieve permanent listing (Gerke et al., 2020). The framework includes structured evidence requirements based on risk and claims, with an emphasis on comparative studies for permanent listing, followed by negotiated prices between manufacturers and the National Association of Statutory Health Insurance Funds after permanent listing (GKV-Spitzenverband, 2022). This model balances rapid market access with robust evidence generation and could inform Poland's framework.

The UK's National Institute for Health and Care Excellence Evidence Standards Framework for Digital Health Technologies provides a tiered approach to evidence requirements based on functionality and risk (NICE, 2022). For addiction DTx making therapeutic claims, this typically involves Tier 3a/3b evidence standards, requiring high-quality RCTs demonstrating effectiveness against relevant comparators, economic impact analysis to assess cost-effectiveness, standards for usability and technical stability, and consideration of equality and diversity throughout the evaluation.

Recent EU regulatory updates, particularly the full implementation of the MDR and ongoing discussions around the European Health Data Space, will also shape the landscape for DTx in Poland and across Europe (European Commission, 2022).

Implementation Challenges and Considerations

Establishing clear and sustainable reimbursement pathways is critical for DTx adoption in Poland (Gordon et al., 2020). Options include value-based pricing models where reimbursement is tied to predefined clinical outcomes, subscription-based access funded through the national health fund, hybrid models involving initial coverage with subsequent adjustments based on real-world performance, integration into existing addiction treatment reimbursement codes, and detailed cost-effectiveness analysis methodologies specific to addiction DTx (Garrison et al., 2015; Whitelaw et al., 2020; Bach, 2012; Meckley et al., 2018; Drummond et al., 2015; Petry et al., 2008).

Successful DTx implementation requires seamless integration into existing clinical workflows and adequate training for healthcare providers (Graham et al., 2006). This includes requirements for intuitive clinician dashboards for patient monitoring, standardized training programs for healthcare providers, guidelines for blended care models, clear documentation standards for DTx use within patient medical records, and addressing skepticism from addiction treatment professionals by providing robust evidence and involving them in co-design processes (Muralidharan et al., 2021; Torous et al., 2018; Schueller et al., 2018; Payne et al., 2015; Apolinário-Hagen et al., 2017).

Incorporating patient perspectives, especially from those with lived experience of addiction and recovery, is crucial for developing acceptable, engaging, and effective DTx (Tempest & Manafò, 2019). The framework should encourage patient involvement in co-design and testing, collection of qualitative data on patient experiences and preferences, and inclusion of patient-reported outcome measures that reflect what matters most to patients in their recovery journey (Slattery et al., 2019; Torous et al., 2020; Staniszewska et al., 2017).

Given the rapid evolution of digital technologies and addiction science, the framework must establish processes for continuous learning and adaptation, including periodic re-evaluation requirements for approved DTx, mandatory post-market surveillance, mechanisms for updating therapeutic content based on new evidence, sunset provisions for obsolete technologies, and standardized reporting of adverse events specific to digital addiction therapeutics (Gagliardi et al., 2019; FDA, 2022; Mohr et al., 2017; Stern & Spitzer, 2020; Bhatt & D'Agostino, 2021).

Limitations and Potential Risks of Digital Therapeutics in Addiction

While promising, DTx for addiction are not without limitations and potential risks that must be acknowledged and mitigated (Torous et al., 2018; Carlo et al., 2019). DTx may exacerbate health disparities if access is limited by cost, device ownership, internet connectivity, or digital literacy (Baumel & Muench, 2020). There's also potential for users to become overly reliant on digital tools, possibly hindering the development of intrinsic coping skills or real-world social support (Bucci et al., 2019).

The highly sensitive nature of addiction data makes DTx platforms attractive targets for breaches, with potentially severe consequences for users (Price et al., 2019). For some individuals, purely digital interventions may lack the crucial human element of empathy, support, and accountability found in traditional therapy (Berry et al., 2019). Data generated by DTx, if not interpreted correctly by clinicians or patients, could lead to inappropriate treatment decisions or undue anxiety (Wilbanks & Friend, 2016).

Poorly designed or unvalidated DTx could offer ineffective advice, fail to detect escalating risk, or even provide harmful content (Firth & Torous, 2015). The framework must require systematic monitoring and reporting of potential negative outcomes, such as increased anxiety, frustration with technology, or worsening of symptoms (Rozental et al., 2014).

Economic Evaluation and Reimbursement Pathways

The sustainable integration of any addiction treatment modality, including innovative approaches like Digital Therapeutics (DTx), into national health systems hinges critically on robust economic evaluation and clearly defined reimbursement pathways. Without these, even the most clinically effective interventions may fail to achieve widespread adoption and impact. This is particularly salient in addiction policy, where the societal and economic burdens of untreated substance use disorders (SUDs) are immense, yet funding for treatment often faces significant competition and scrutiny (National Academies of Sciences, Engineering, and Medicine, 2016).

Cost-Effectiveness Analysis Framework

A comprehensive cost-effectiveness analysis (CEA) framework is essential for demonstrating the value of addiction treatments. For a country like Poland, considering the adoption of new interventions such as DTx, a modified CEA approach is recommended. This approach should not only capture immediate healthcare savings but also broader societal benefits, aligning with international best practices in health economics (Drummond et al., 2015).

Effective addiction treatments, including DTx, can lead to substantial reductions in healthcare utilization. This includes fewer hospitalizations, decreased emergency department visits, and reduced need for managing comorbidities exacerbated by SUDs. For instance, opioid substitution therapy upon prison release has been shown to be cost-effective by reducing relapse and associated healthcare costs (Sexton et al., 2016). While the evidence base for DTx-specific direct cost savings in addiction is still maturing, early indications and analogous applications in mental health suggest potential. Engagement with certain DTx for SUDs aims to reduce relapse rates, which in turn could decrease costly acute care episodes (SAMHSA, 2023a). However, rigorous, large-scale studies are needed to quantify these savings robustly for addiction-specific DTx.

SUDs significantly impair an individual's ability to maintain employment and productivity. Effective treatment can reverse these trends, leading to increased employment rates, reduced absenteeism, and enhanced on-the-job performance. These productivity gains translate into broader economic benefits for society, including increased tax revenue and reduced reliance on disability benefits (McCollister & French, 2003; Zarkin et al., 2020). While the commonly cited statistic that every dollar invested in addiction treatment yields $4 to $7 in reduced drug-related crime and criminal justice costs (NIDA, 2020) is based on older data and may vary by context and treatment type, more recent comprehensive economic analyses continue to affirm substantial societal returns (Murphy & Polsky, 2016; Ettner et al., 2022).

Beyond direct healthcare and productivity, SUDs often necessitate increased use of social services, including housing support, child welfare services, and criminal justice system involvement. Treatment can alleviate these burdens. For example, drug treatment courts, which integrate judicial oversight with treatment, have demonstrated reductions in recidivism and associated costs in various jurisdictions (National Institute of Justice, 2022). DTx, by potentially improving treatment adherence and extending support, could contribute to these savings, although specific research in this area is nascent.

The ultimate goal of healthcare interventions is to improve both the length and quality of life. Quality-Adjusted Life Years (QALYs) are a standard metric in health economics that capture this dual benefit (ICER, 2024). Addiction treatment has been shown to significantly increase QALYs. Research indicates that active SUDs are associated with substantial decrements in health-related quality of life, and successful treatment can lead to QALY gains (Nosyk et al., 2021). A recent study estimated that buprenorphine treatment for opioid use disorder yields 1.21 QALYs over a lifetime horizon compared to no treatment, under status quo conditions which include current rates of treatment retention and relapse (Fairley et al., 2024). Cost-effectiveness analyses often use a threshold for what society is willing to pay per QALY gained; interventions falling below this threshold are generally considered cost-effective.

Research consistently indicates that effective addiction treatments yield substantial returns. The specific benefit-cost ratio can vary by treatment type, population, and the breadth of outcomes measured (Murphy & Polsky, 2016). DTx products, to gain acceptance and funding, must demonstrate a comparable or superior economic value proposition through rigorous studies tracking not just clinical outcomes but also these broader economic impacts.

Economic evaluation of DTx presents unique challenges. The appropriate time horizon for measuring benefits can be complex, as some benefits may accrue long after the initial intervention period (Torbjørnsen et al., 2022). Furthermore, the rapid pace of technological development means digital platforms can face obsolescence, requiring ongoing updates or replacement, which complicates long-term cost-effectiveness modeling (HIMSS, 2021). The value assessment must also consider the costs associated with data infrastructure, interoperability, and ongoing technical support.

Proposed Reimbursement Models

Establishing clear and sustainable reimbursement models is crucial for the widespread adoption of effective addiction treatments, including DTx. Three potential pathways, which can be adapted and potentially combined, offer promising approaches to this challenge.

Value-Based Reimbursement (VBR) shifts payment from volume of services to the value and quality of care provided. Payments are tied to the achievement of predefined clinical and patient-reported outcomes. The U.S. Centers for Medicare & Medicaid Services has been actively promoting value-based programs across healthcare (CMS, 2024a). SAMHSA has explored VBP specifically for SUD services, highlighting its potential to incentivize providers to focus on long-term recovery (SAMHSA, 2023b). States like Oregon have also implemented VBP initiatives within their Medicaid programs, which can include addiction services (Oregon Health Authority, n.d.).

For SUDs, outcomes could include sustained abstinence, treatment adherence (which DTx can track effectively), reduction in substance use, improvements in functioning, and patient-reported quality of life. For DTx, this could mean payers reimburse based on engagement metrics or achievement of specific, validated clinical milestones (Gordon et al., 2020). The Patient-Centered Opioid Addiction Treatment Alternative Payment Model developed by ASAM is an example of a value-based approach for OUD treatment (ASAM, n.d.-b).

Defining and measuring outcomes robustly can be complex, requiring validated tools and reliable data collection. Risk adjustment is also necessary to ensure providers are not penalized for treating more complex cases (SAMHSA, 2023b). Data infrastructure to track and report outcomes is essential. Furthermore, VBR models can impose significant administrative burdens on providers and may inadvertently lead to "cherry-picking" of patients perceived as easier to treat if not carefully designed (Berwick et al., 2021).

The Subscription Model involves payers paying a recurring fee for access to a portfolio of approved DTx products or a specific DTx intervention. This model is common for software and digital services. In healthcare, Germany's DiGA pathway allows physicians to prescribe approved DTx, which are then reimbursed by statutory health insurance, often through negotiated prices that can resemble subscription or licensing fees (Federal Institute for Drugs and Medical Devices, 2023).

This approach could be particularly suitable for DTx, where the marginal cost of delivering the software to an additional user is low. It could provide predictable revenue for DTx developers and predictable costs for payers. A national health system like Poland's NFZ could negotiate access for all eligible patients with a particular SUD.

Price negotiation can be complex, requiring clear value propositions and evidence of effectiveness. Ensuring that the subscription provides value requires ongoing assessment of utilization, engagement, and outcomes (Gordon et al., 2020). There's also a risk of "shelf-ware" if DTx products are subscribed to but not actively used or integrated into care pathways, leading to inefficient spending.

Hybrid Funding combines different funding streams. For instance, initial coverage for a DTx or a new treatment program might come from the National Health Fund, with supplemental funding from addiction-specific budgets, public health grants, or even social impact bonds. Many countries use hybrid funding for health and social programs. For example, in the UK, addiction services are primarily funded through local government public health grants, but there can be interplay with NHS funding for comorbid conditions or specialized services (NHS England, 2019).

This approach could facilitate the initial adoption of promising but not yet fully established interventions like DTx. Pilot programs could be funded through specific grants, and if proven effective and cost-effective, they could transition to mainstream reimbursement. Addiction-specific budgets could cover aspects not typically reimbursed by standard health insurance, such as peer support components integrated with a DTx or wraparound services.

Coordinating multiple funding streams can be administratively complex and may lead to fragmentation. Ensuring long-term sustainability if grant funding is time-limited is a key concern, potentially leading to service disruption if mainstream funding is not secured (Humphreys & McLellan, 2011).

It is crucial to design reimbursement models that promote health equity rather than exacerbate disparities. VBR models must incorporate robust risk adjustment to avoid penalizing providers serving socioeconomically disadvantaged or clinically complex populations (SAMHSA, 2023b). Subscription models for DTx should consider strategies to ensure access for individuals with limited digital literacy or access to necessary technology, potentially through publicly funded devices or support programs (Crawford & Serhal, 2020). Patient cost-sharing, if implemented, must be structured to avoid creating financial barriers for low-income individuals, as this can significantly impact DTx adoption and treatment adherence (Reed et al., 2019).

Pharmaceutical and technology companies play a significant role in developing new treatments, including DTx, and subsequently in advocating for favorable reimbursement policies. While industry innovation is vital, it is important to ensure that reimbursement decisions are driven by independent evidence of clinical and cost-effectiveness, public health needs, and patient benefit, rather than solely by commercial interests (Lexchin, 2012). Transparent processes for evaluating new technologies and negotiating prices are essential.

Implementation Pilot: Alcohol Use Disorder in Poland

The proposal to begin with a pilot program focusing on Alcohol Use Disorder (AUD) in Poland is strategically sound. AUD is a significant public health challenge globally and in Poland. While the WHO (2018) reported that in 2016 an estimated 2.4% of the Polish population had an alcohol use disorder, with high rates of heavy episodic drinking, it is crucial to consult the most recent national data from sources like Poland's National Centre for Addiction Prevention or recent EMCDDA/OECD reports for current policy planning, as prevalence rates and consumption patterns can change over time (EMCDDA, 2023; OECD, 2023).

AUD treatment has relatively well-established clinical endpoints that can be used to measure the effectiveness of interventions, including DTx. These include reduction in the number of heavy drinking days (NIAAA, 2015), percentage of days abstinent (NIAAA, 2015), changes in scores on standardized AUD screening and assessment tools (Babor et al., 2001), improvements in liver function tests (where clinically indicated), and patient-reported outcomes on cravings, quality of life, and functional improvement (Witkiewitz et al., 2020).

DTx interventions for AUD can offer psychoeducation, cognitive behavioral therapy exercises, motivational interviewing techniques, craving management tools, and relapse prevention planning (SAMHSA, 2023a; Lin et al., 2019). Their accessibility via smartphones can help overcome barriers like stigma and geographical distance to treatment centers, potentially increasing engagement for some individuals.

While DTx offer promise, their adoption in Poland would face potential barriers. These could include varying levels of digital literacy and access to smartphones/internet, particularly among older or more marginalized populations (Eurostat, 2023). Provider attitudes and readiness to integrate DTx into clinical workflows, along with the need for training and support, are critical (Apolinário-Hagen et al., 2020). Ensuring data privacy and security in line with GDPR and national regulations is paramount. Furthermore, the existing healthcare infrastructure's capacity to support DTx integration, including interoperability with electronic health records, would need careful assessment (European Commission, 2018).

Comparative Policy Insights & Challenges

Effective addiction treatment is multifaceted. The American Society of Addiction Medicine promotes a chronic care model, emphasizing individualized, evidence-based treatment across a continuum of care (ASAM, n.d.-a). This includes Medications for Addiction Treatment for OUD and Alcohol Use Disorder (NIDA, 2023; Legislative Analysis and Public Policy Association, 2024), behavioral therapies, and increasingly, digital health interventions (SAMHSA, 2023a; Link et al., 2023).

International reimbursement examples offer valuable insights. In the United States, reimbursement is fragmented across private insurance, Medicaid, Medicare, and grants. VBP models are gaining traction (CMS, 2024a; SAMHSA, 2023b). Some states are using Medicaid waivers to expand SUD treatment coverage. Specific DTx like reSET® and reSET-O® received FDA authorization and achieved some payer coverage, though the company later faced financial difficulties, highlighting market access challenges (FDA, 2017; FDA, 2018; Business Wire, 2023).

In the United Kingdom, the National Institute for Health and Care Excellence provides guidance on cost-effective treatments, which influences commissioning by local authorities and the NHS (NICE, n.d.). While DTx for mental health are emerging, specific reimbursement pathways for SUD DTx are still developing, often relying on local commissioning decisions or pilot funding (NHS, n.d.).

Germany's DiGA Fast-Track process allows for the provisional reimbursement of approved DTx while further evidence is collected, offering a clearer pathway for DTx developers (Federal Institute for Drugs and Medical Devices, 2023). This model is seen as a leader in Europe for structured DTx assessment and reimbursement.

The COVID-19 pandemic significantly accelerated the adoption of telehealth for addiction treatment, with many countries implementing temporary or permanent reimbursement flexibilities for remote consultations and services (SAMHSA, 2021; OECD, 2020). This shift has created a more favorable environment for DTx, as both providers and patients have become more accustomed to digitally delivered care. However, the long-term sustainability of these pandemic-era reimbursement policies remains a key question, with ongoing debates about appropriate payment rates for telehealth versus in-person care and the evidence standards for new digital interventions (CMS, 2024b).

Current challenges in addiction policy implementation include persistent stigma, which remains a major barrier to help-seeking, adequate funding for addiction services, and policy prioritization globally (World Drug Report, 2023; Livingston et al., 2012). Workforce shortages, including a lack of trained addiction specialists, primary care physicians comfortable with treating SUDs, and digital health literate professionals, hamper service delivery (SAMHSA, 2022). Implementing VBP and effectively evaluating new interventions like DTx requires robust data collection, interoperability, and analysis capabilities, which are often underdeveloped (HIMSS, 2021).

SUDs frequently co-occur with mental and physical health conditions. Integrating addiction treatment into primary care (Asgari et al., 2018; SAMHSA, n.d.) and mental health services is crucial but challenging due to siloed funding and care systems. Securing consistent and adequate funding for the full continuum of addiction care, from prevention and harm reduction to treatment and recovery support, is an ongoing struggle in many countries (National Academies of Sciences, Engineering, and Medicine, 2016).

Implementation challenges specific to Digital Therapeutics include disparities in digital literacy and access to reliable internet and appropriate devices, which can create a "digital divide," potentially excluding vulnerable populations from benefiting from DTx if not addressed through supportive policies and programs (Crawford & Serhal, 2020). Effectively integrating DTx into existing clinical workflows requires careful planning, provider training, and often, redesign of care processes. Lack of seamless integration can lead to low adoption by clinicians (Apolinário-Hagen et al., 2020).

Ensuring the security and privacy of sensitive patient data collected by DTx is paramount, requiring compliance with regulations like GDPR and robust data governance frameworks (Gordon & Fairhall, 2021). DTx require ongoing maintenance, updates to remain compatible with evolving operating systems, and technical support. The costs associated with this long-term maintenance must be factored into economic evaluations and funding models (HIMSS, 2021). The rapid evolution of DTx can outpace traditional research and regulatory timelines, creating challenges in generating the robust, long-term evidence of effectiveness and cost-effectiveness that payers often require (FDA, 2023).

While DTx offer significant potential, it is important to maintain a balanced perspective. Real-world engagement and retention with DTx can be lower than in clinical trials, limiting their overall impact if users do not consistently use the tools as intended (Torous et al., 2020; Tofighi et al., 2019). The evidence base for DTx effectiveness may be stronger for some SUDs or populations than others. More research is needed to understand who benefits most and under what conditions (SAMHSA, 2023a).

Without proactive measures, reliance on DTx could inadvertently exacerbate health disparities for those lacking digital access or skills (Crawford & Serhal, 2020). Concerns exist regarding the collection, use, and ownership of large amounts of personal health data generated by DTx, particularly by commercial entities. Clear ethical guidelines and robust patient consent processes are essential (Gordon & Fairhall, 2021).

There's a risk that focusing heavily on technological solutions might detract from the fundamental need for human connection, comprehensive psychosocial support, and addressing social determinants of health in addiction treatment (Gainsbury & Blaszczynski, 2017). DTx are best viewed as tools to augment, not replace, comprehensive care. The development and promotion of DTx are often driven by commercial entities. It is crucial to ensure that public health goals, patient well-being, and equitable access remain primary, with transparent evaluation processes independent of commercial influence (Lexchin, 2012; Facher et al., 2021).

The economic evaluation and reimbursement pathways for addiction treatment, including DTx, must be thoughtfully designed, rigorously evaluated, and continually adapted. By adopting a comprehensive CEA framework, exploring flexible and equitable reimbursement models, and critically assessing both the promise and challenges of new technologies, Poland and other nations can enhance the sustainability and impact of their addiction policies, ultimately improving public health and societal well-being.

Pilot Implementation Strategy

A phased implementation approach represents the optimal pathway for testing the evaluation framework and establishing real-world evidence (RWE) for Digital Therapeutics (DTx) in the Polish healthcare context, particularly for alcohol use disorder (AUD). This strategy acknowledges the necessity for gradual system transformation while building robust evidence for effectiveness and cost-effectiveness (National Academies of Sciences, Engineering, and Medicine, 2017). The use of RWE has gained increasing recognition globally, with regulatory bodies like the U.S. Food and Drug Administration (FDA) establishing frameworks for its use in regulatory decision-making (FDA, 2023a; FDA, n.d.-a). This pilot aims to inform the responsible and effective integration of DTx into the Polish healthcare system.

Phase 1: Initial Assessment and Selection (Months 1-6)

This foundational phase is critical for establishing a transparent, evidence-based, and stakeholder-inclusive process for DTx selection and pilot design. It proactively addresses potential ethical, cultural, and regulatory considerations specific to Poland.

The establishment of a DTx Evaluation Committee ensures diverse expertise and perspectives, fostering buy-in and addressing potential ethical, clinical, and implementation challenges from the outset. This approach aligns with best practices in health technology assessment (HTA) (Kristensen et al., 2017). The committee should include representatives from the Ministry of Health to ensure alignment with national health priorities and policy frameworks, including Poland's National Health Programme. The Narodowy Fundusz Zdrowia (NFZ - National Health Fund) participation is crucial for future reimbursement considerations and understanding payer perspectives on value and affordability. The experience of countries like Germany, where the Federal Joint Committee (G-BA) plays a key role in assessing DTx for reimbursement (Gerhards et al., 2021), highlights the importance of early payer involvement.

Addiction specialists from organizations such as PARPA (State Agency for Prevention of Alcohol-Related Problems) will provide clinical expertise on AUD, current Polish treatment landscapes, and the practical utility of DTx in patient care. Patient advocates ensure the patient perspective remains central, focusing on usability, acceptability, cultural relevance, and ethical considerations like data privacy and equity of access, particularly for vulnerable populations. Digital health experts and technologists will evaluate technical robustness, data security (compliance with GDPR and Polish data protection laws), interoperability, and UI/UX design. The FDA's Digital Health Center of Excellence provides a model for such specialized oversight (FDA, 2023b).

Implementation scientists, ethicists, legal experts, and primary care physicians round out the committee, providing expertise in translating evidence-based interventions into routine practice, addressing ethical implications and data governance, and offering insights on integrating DTx into primary care settings where many individuals with AUD may first seek help (World Health Organization, 2010). The committee will define clear evaluation criteria, review applications, select DTx for the pilot, and oversee the development of implementation protocols.

The focus on AUD is strategic, as it represents a significant public health challenge in Poland. Estimates suggest that around 600,000 people in Poland suffer from alcohol dependence, with a much larger group (around 2.5 million) drinking harmfully or hazardously (State Agency for Prevention of Alcohol-Related Problems [PARPA], 2021). Globally, alcohol use is a leading risk factor for disease burden (World Health Organization, 2018).

A call for applications from DTx developers should require submission of evidence demonstrating clinical efficacy through at least one randomized controlled trial or robust observational study. While the evidence base for AUD-specific DTx is still growing, some digital interventions have shown promise (Kaner et al., 2017; Riper et al., 2018). Applications should also include information on safety and usability, mechanism of action (e.g., CBT, Motivational Interviewing), data security and privacy plans, technical specifications, and cultural and linguistic adaptation for the Polish context. Lack of such adaptation is a key barrier to DTx uptake (Hollis et al., 2017).

The committee will select 2-3 products that meet minimum evidence standards for pilot testing, using a predefined scoring matrix emphasizing strength of existing clinical evidence, potential for cost-effectiveness, user-centered design, technical feasibility, commitment to cultural adaptation, and alignment with Polish healthcare system needs. This limited selection allows for comparative evaluation while remaining manageable for a pilot.

Implementation protocols and evaluation metrics will be developed, including detailed SOPs for integrating DTx into participating treatment centers and potentially primary care settings. The Consolidated Framework for Implementation Research (CFIR) can guide this process (Damschroder et al., 2009). Evaluation metrics will encompass clinical outcomes (changes in alcohol consumption, craving scores, mental health comorbidities, quality of life), engagement metrics, user experience, implementation outcomes, healthcare resource utilization, and equity metrics to assess reach and impact across different socioeconomic groups, age groups, and geographical locations.

Phase 2: Controlled Implementation (Months 7-18)

This phase involves the practical deployment of selected DTx products in real-world clinical settings, focusing on gathering robust data and understanding implementation dynamics.

The selected DTx products will be deployed in 8-12 addiction treatment centers and select primary care practices across diverse geographical regions. This diversity enhances the generalizability of findings and identifies region-specific implementation challenges or successes, including issues related to digital infrastructure and literacy (Central Statistical Office of Poland [GUS], 2022). Selected centers should demonstrate capacity for research or quality improvement, adequate IT infrastructure, willing staff, and commitment to supporting patients with varying levels of digital literacy.

Integration with existing care is paramount; DTx should be implemented as an adjunct to, not a replacement for, existing evidence-based treatments. Collaboration with primary care physicians will be explored for identification, referral, and co-management pathways.

The pilot will enroll 800-1,200 patients with varying severity of AUD to provide sufficient statistical power for meaningful analysis while remaining feasible. Including patients across the AUD spectrum (mild, moderate, severe) will help determine the optimal target population. Ethical considerations must be prioritized, including comprehensive informed consent in Polish, robust data privacy and security measures compliant with GDPR and Polish regulations, Bioethics Committee approval (National Science Centre Poland, n.d.), and strategies to mitigate the digital divide for those with limited digital access or skills.

Real-world data collection will focus on clinical outcomes, engagement patterns, user experience, and implementation challenges. The FDA's RWE Program Framework emphasizes fit-for-purpose data (FDA, n.d.-a). Data sources may include EHRs (where interoperable), DTx platform analytics, Patient-Reported Outcomes (PROs), and clinician-reported data. Some studies on PDTs for substance use disorders have shown promising real-world outcomes (Christensen et al., 2022), though low engagement remains a known challenge (Torous et al., 2020).

Interim analyses at 6 and 12 months will allow for early problem identification, adaptive adjustments to protocols, preliminary efficacy/engagement signals, and assessment of any emerging ethical or equity concerns. Findings will be reported to the DTx Evaluation Committee for ongoing oversight and guidance.

Phase 3: Evaluation and Framework Refinement (Months 19-24)

The final phase focuses on analyzing comprehensive data, refining the Polish DTx evaluation framework, and planning for broader, sustainable adoption.

A comprehensive analysis of pilot outcomes will include statistical analysis of clinical effectiveness, engagement, user experience, and qualitative analysis of implementation facilitators and barriers. Subgroup analyses will identify differential effects based on demographics, AUD severity, or digital literacy. Cost-effectiveness analysis is crucial for NFZ decision-making (Garrison et al., 2018), evaluating economic impact, implementation costs, and potential healthcare savings. An honest assessment of limitations will identify any negative consequences observed, such as increased patient anxiety, data breaches, or over-reliance on technology.

The Polish DTx evaluation framework will be refined based on implementation learnings, focusing on minimum evidence standards for the Polish context, culturally relevant outcome measures, and best-practice guidelines for equitable DTx implementation. This contextualization ensures the framework is tailored to the Polish healthcare system, regulatory environment (e.g., Act on Medical Devices), and patient population needs, including digital inclusion strategies. This learning health system approach is vital for continuous improvement (Greene et al., 2012).

A scaling strategy for successful interventions will define clear benchmarks for clinical impact, user engagement, cost-effectiveness, and equity. For successful DTx, a broader, phased implementation will be planned, potentially starting with regions or populations where it's most needed and feasible. Key components include training and capacity building for healthcare professionals, addressing technical infrastructure and interoperability needs, identifying policy and regulatory adjustments, building public awareness, developing strategies for engaging traditional providers, and planning for long-term sustainability. Contingency planning will outline steps if the pilot shows limited effectiveness or significant challenges.

Establishing recommendations for permanent reimbursement pathways for effective DTx products is essential for sustainable, equitable access. International models offer valuable insights: Germany's DiGA "fast-track" process provides provisional reimbursement based on initial evidence with ongoing RWE collection (Bundesinstitut für Arzneimittel und Medizinprodukte [BfArM], n.d.) and is widely discussed as an example for other countries (Stern et al., 2022). The United Kingdom's NICE evaluates digital health technologies using an evidence standards framework (NICE, n.d.), while the United States has a more fragmented approach (Patel & Torous, 2019). France recently introduced a fast-track reimbursement pathway (PECAN) for certain digital medical devices (HAS, 2023).

Poland-specific considerations must align with NFZ procedures and Polish law, including defining value, considering budget impact, and potentially exploring outcomes-based agreements. Continuous dialogue with the NFZ is vital to develop acceptable and sustainable reimbursement models, including defining what constitutes "therapeutic benefit" or added value in the Polish context.

This comprehensive pilot implementation strategy, grounded in evidence, international experiences, and a strong focus on the Polish context, provides a robust foundation for integrating effective and equitable DTx into addiction treatment in Poland. By addressing the unique challenges of the digital divide, regulatory specifics, and healthcare system integration, this approach maximizes the potential for successful implementation while minimizing risks and ensuring responsible innovation in addiction treatment.

Stakeholder Engagement and Capacity Building

Successful implementation of innovative addiction policies, particularly those incorporating Digital Therapeutics (DTx), hinges on meaningful engagement with all relevant stakeholders and the concurrent development of necessary capabilities within the healthcare system and the community. Addiction represents a complex global health challenge, with the United Nations Office on Drugs and Crime (UNODC) reporting approximately 296 million people used drugs in 2021, and an estimated 39.5 million people worldwide suffered from drug use disorders (UNODC, 2023, p. 40). Effective responses require a coordinated, multi-level approach that leverages the unique strengths and perspectives of each stakeholder group, alongside targeted efforts to build the infrastructure, human capital, and equitable frameworks needed to support new treatment modalities. While DTx offer significant promise, their integration must be approached with careful consideration of potential challenges, including equity, ethics, and the need for robust evidence (Tofighi et al., 2022).

Key Stakeholder Roles

Healthcare Providers

Healthcare providers represent the frontline of addiction treatment implementation, making their engagement, proficiency, and understanding of both the benefits and limitations of DTx essential for effective deployment. Comprehensive training programs for addiction specialists and primary care providers must be established, as these professionals often serve as the first point of contact for individuals with substance use disorders (SAMHSA, 2023). These training initiatives should cover the evidence base for specific DTx, including findings from systematic reviews and meta-analyses (e.g., Dugdale et al., 2021; Tofighi et al., 2022), appropriate patient selection criteria, technical functionalities, ethical considerations around informed consent and data privacy, prescription protocols, and methods for monitoring patient engagement and outcomes (Torous et al., 2020). The Shapiro Administration in Pennsylvania has specifically identified workforce concerns as a critical issue in addiction treatment, emphasizing the need for enhanced provider support and training (Pennsylvania Department of Drug and Alcohol Programs [DDAP], 2024b). Research consistently demonstrates that effective training in evidence-based practices, adapted for digital delivery, improves provider confidence and competence, ultimately leading to better patient outcomes (Beidas & Kendall, 2010).

For DTx to achieve meaningful adoption, they must be seamlessly integrated into existing clinical workflows rather than functioning as burdensome add-ons. This integration necessitates incorporating DTx into electronic health records where feasible, developing clear protocols for their use within comprehensive treatment plans, and ensuring interoperability with other health IT systems (SAMHSA, 2023). The National Institutes of Health (NIH) actively encourages research into implementation strategies for DTx, acknowledging the significant challenges of integrating these tools into real-world clinical settings (NIH, 2023). Additionally, treatment guidelines from authoritative bodies such as the American Society of Addiction Medicine should be regularly updated to reflect the availability and appropriate use of evidence-based DTx, considering both their potential benefits and limitations.

The development of blended care models that combine digital and in-person interventions represents a particularly promising approach in addiction treatment. These models enhance treatment accessibility, engagement, and personalization by balancing technological scalability with essential human interaction (Haug et al., 2017). Organizations like Eleanor Health have begun implementing such blended care approaches in addiction and mental health treatment services (Business Wire, 2022), though peer-reviewed evidence on outcomes from commercial implementations remains necessary for broader validation. These hybrid models allow for the scalability advantages of DTx while preserving the crucial human element of therapeutic support that remains vital for many individuals in recovery.

Patients and Patient Organizations

As the ultimate end-users of DTx, patients must be actively involved in development and implementation processes to ensure these tools are acceptable, usable, effective, and respectful of their autonomy and privacy. Co-design and iterative user testing with individuals who have lived experience of addiction are essential for developing DTx that genuinely meet their needs, preferences, and cultural contexts (Yardley et al., 2015). This collaborative approach ensures interfaces are intuitive, content is relevant and culturally appropriate, and privacy concerns are transparently addressed. Feedback mechanisms should operate continuously, allowing for ongoing improvement of DTx after initial deployment. The development of patient-reported outcome measures specific to DTx can further help capture the authentic patient experience.

Peer support networks play a vital role in promoting DTx adoption and adherence. Peer support specialists—individuals in recovery who help others—can share experiences, provide encouragement, troubleshoot minor technical issues, and bridge digital literacy gaps (Bassuk et al., 2016). Integrating peer support into DTx programs enhances engagement and provides a sense of community that is often crucial for sustained recovery (Ashford et al., 2020). These networks can function effectively both online, potentially integrated within DTx platforms, and through in-person interactions.

Clear, accessible, and culturally sensitive educational materials must be developed to help patients understand what DTx are, how they function, their potential benefits and limitations, data privacy implications, and best practices for effective and safe use. This information should include explicit details on data rights and usage policies (SAMHSA, 2023). Co-developing these materials with patients and patient organizations ensures they address common concerns in understandable language. Addressing digital health literacy is paramount, as low literacy levels can present significant barriers to accessing and benefiting from digital health interventions (Nouri et al., 2020; Chittamuru et al., 2021).

Payers and Policy Makers

Payers and policymakers fundamentally shape the landscape for DTx adoption through funding decisions, regulatory frameworks, value assessment methodologies, and strategic initiatives that promote both innovation and equity. A significant barrier to widespread DTx implementation is the lack of clear and consistent reimbursement pathways (SAMHSA, 2023). Payers, including public and private insurers, need to establish transparent processes for evaluating the clinical and economic evidence for DTx and making coverage decisions. Germany's DiGA (Digital Health Applications) framework offers an instructive model where approved DTx can be prescribed by doctors and reimbursed by statutory health insurance (Bundesinstitut für Arzneimittel und Medizinprodukte [BfArM], n.d.). In the United States, efforts continue to establish dedicated benefit categories and payment codes for DTx, though progress has been incremental (Levin, 2021). The Shapiro Administration's stakeholder engagement tours in Pennsylvania exemplify efforts to gather input that informs policy development, including aspects related to treatment access and funding mechanisms (DDAP, 2024a).

Effective policy implementation requires robust data on budget impact, clinical effectiveness, and overall value of DTx investments. This includes assessing cost-effectiveness compared to standard care, potential for reducing healthcare utilization such as hospitalizations, and impact on patient outcomes, quality of life, and health equity (SAMHSA, 2023). Value assessment frameworks should consider both quantitative metrics and qualitative benefits, including patient-reported experiences and contributions to long-term recovery capital. The Oklahoma Department of Mental Health and Substance Abuse Services' implementation of digital health tools likely involves such ongoing assessments to justify continued investment (SAMHSA, 2023).

Governments and regulatory bodies must adapt existing policies or create new frameworks to facilitate the safe, effective, and equitable integration of DTx into addiction care systems. This involves establishing clear regulatory pathways for DTx, such as those being developed by the U.S. Food and Drug Administration for software as a medical device (FDA, 2023). Policies must ensure robust data security and privacy standards consistent with HIPAA in the U.S. or GDPR in Europe, promote interoperability between systems, and address ethical considerations related to data use and algorithmic bias. International examples beyond Germany's DiGA include the UK's NHS Digital Technology Assessment Criteria (DTAC), which helps evaluate tools for the NHS Apps Library (NHS, n.d.), and evolving frameworks in countries like Canada and Australia. Initiatives such as New Jersey's Behavioral Health Integration demonstrate commitment to systemic policy adjustments for improved behavioral healthcare through multi-stakeholder engagement (New Jersey Department of Human Services, n.d.).

Addressing Equity, Ethics, and Potential Risks in DTx Implementation

While DTx hold considerable promise for expanding addiction treatment access, their implementation must proactively address potential downsides to ensure they do not exacerbate existing health disparities or introduce new ethical challenges. Significant disparities in access to technology and digital literacy persist across socioeconomic, geographic, and demographic lines (NASEM, 2021; Chambers et al., 2022). Effective DTx implementation strategies must include measures to mitigate these divides, such as providing subsidized devices or data plans, offering community-based access points, and ensuring DTx are designed for low-bandwidth environments. Furthermore, DTx must be accessible to individuals with disabilities, adhering to established accessibility guidelines. Cultural adaptation of DTx content and delivery is crucial to ensure relevance and effectiveness for diverse populations, including racial and ethnic minorities, LGBTQ+ individuals, and older adults (Ben-Zeev et al., 2018).

The collection and use of sensitive patient data through DTx raise significant ethical concerns that must be addressed through policy. Robust frameworks for data privacy, security, and governance are essential, including clear policies on data ownership, informed consent for data use, and transparency in how algorithms analyze patient information (Vayena et al., 2018). There is a legitimate risk that over-reliance on DTx could reduce meaningful human connection in treatment, which remains a critical component of recovery for many individuals (Hollis et al., 2017). Well-designed DTx should aim to augment, not replace, human interaction unless evidence clearly supports standalone efficacy and aligns with patient preferences. Additional concerns include technology dependence, the potential for algorithmic bias to perpetuate disparities, and the long-term sustainability of DTx programs after initial implementation funding ends (Crawford & Serhal, 2020).

Adoption of DTx may face resistance from various stakeholders that must be acknowledged and addressed through policy. Some traditional treatment providers may be skeptical of new technologies or concerned about their changing professional roles (Brooks et al., 2022). Patients may harbor privacy concerns or simply prefer in-person care models. Recovery communities might worry about the depersonalization of treatment approaches. Open dialogue and co-design processes can help address these legitimate concerns. Additionally, the growing commercial interest in DTx development necessitates vigilance regarding potential conflicts of interest, ensuring that patient welfare and evidence-based practices remain paramount over profit motives (Parker et al., 2019). Policymakers must guard against the risk that DTx might be promoted primarily as cost-cutting measures to replace human providers, rather than as tools to enhance and extend care, which could negatively impact quality and equity.

Capacity Building Initiatives

Beyond engaging stakeholders and mitigating risks, a concerted policy effort is needed to build the systemic capacity required to support the widespread, equitable, and effective implementation of DTx for addiction. The development of national or regional DTx knowledge hubs and resource centers represents a foundational element of this infrastructure. A centralized knowledge hub, such as the proposed Polish DTx knowledge hub, can serve as a critical resource for all stakeholders by curating and disseminating evidence-based information on available DTx, implementation best practices, training materials, regulatory guidance, and ethical frameworks (NHS, n.d.). Such centers can foster research collaborations and facilitate knowledge exchange, ensuring that information remains current and rigorously vetted.

Building a digitally competent healthcare workforce through comprehensive training programs is essential for successful DTx implementation. This extends beyond training on specific DTx platforms to include broader digital health competencies such as understanding health informatics, data analytics, telehealth delivery, cybersecurity principles, and the ethical implications of digital health interventions (Torous et al., 2020). These competencies should be integrated into medical and nursing school curricula, as well as continuing professional development programs. Addressing workforce shortages and burnout, as highlighted by the DDAP in Pennsylvania (DDAP, 2024b), is also crucial, as an overstretched workforce will inevitably struggle to adopt new technologies effectively.

Healthcare organizations, particularly smaller clinics or those in underserved areas, often require technical assistance to implement DTx effectively. This support can include IT infrastructure upgrades, EHR integration, workflow redesign, change management processes, data analysis capabilities, and guidance on navigating complex privacy regulations (SAMHSA, 2023). Such assistance, potentially offered through public-private partnerships or government initiatives, can help bridge the gap between the theoretical availability of DTx and their practical application in diverse clinical settings with varying resource levels.

Public awareness campaigns addressing digital health literacy, addiction stigma, and realistic expectations for DTx constitute another critical capacity-building element. These campaigns improve digital literacy, empowering individuals to engage confidently and critically with DTx and other digital health tools (Estacio et al., 2017). Simultaneously, campaigns that challenge misconceptions about addiction and promote understanding can encourage more individuals to seek help, including through newly available digital avenues (Corrigan et al., 2014). These campaigns should be culturally tailored, co-designed with community members, and strategically designed to reach diverse populations to ensure equitable access and uptake of DTx, while also clearly communicating both the benefits and limitations of these technologies.

By systematically engaging stakeholders, proactively addressing ethical and equity concerns, and investing in these capacity-building initiatives, policymakers and healthcare systems can create an environment conducive to the successful, responsible, and equitable integration of digital therapeutics. This comprehensive approach will ultimately enhance the quality, accessibility, and effectiveness of addiction treatment and recovery supports, leveraging technology to improve lives while upholding core healthcare values and addressing one of our most pressing public health challenges.

Policy and Regulatory Considerations

The successful integration and scaling of Digital Therapeutics (DTx) for addiction treatment hinges on the development of supportive and agile policy and regulatory environments. These frameworks must meticulously balance the drive for innovation with the imperative of patient safety and efficacy, particularly when addressing the complexities of substance use disorders (SUDs) and behavioral addictions. Addiction remains a significant global public health challenge, with approximately 35 million people estimated to suffer from drug use disorders in 2019 (United Nations Office on Drugs and Crime [UNODC], 2021). The troubling reality that only 1 in 8 people with drug use disorders receive treatment (UNODC, 2021) highlights a complex issue influenced not only by treatment accessibility but also by factors such as stigma, low problem recognition, lack of motivation to change, and system capacity limitations (World Health Organization, 2022; National Institute on Drug Abuse [NIDA], 2020).

In the European Union, an estimated 83.4 million adults (29%) have used an illicit drug at some point, with cannabis being the most common (European Monitoring Centre for Drugs and Drug Addiction [EMCDDA], 2023a). High-risk opioid use affects approximately 0.36% of the EU adult population, equivalent to 1 million high-risk opioid users (EMCDDA, 2023a). In Poland specifically, recent data indicates that approximately 2.5% of adults reported using illicit drugs in the past year, with cannabis being the most prevalent, and an estimated 100,000-150,000 high-risk drug users, primarily opioids (National Centre for Addiction Prevention Poland, 2022). These statistics underscore the critical need for effective and accessible treatment options, including innovative approaches like DTx.

Regulatory Pathway Clarification

A clear, predictable, and efficient regulatory pathway is paramount for fostering DTx development and adoption. Poland's Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPLWMiPB) plays a critical role, operating within the broader EU regulatory landscape for medical devices (European Medicines Agency [EMA], 2023). While URPLWMiPB oversees medical devices, its specific authority for standalone DTx, particularly those with complex software or AI components, needs clear delineation. This may require updated national legislation to align with agencies like Germany's BfArM or the FDA in terms of specialized digital health oversight (Polish Ministry of Health, 2023).

DTx, defined as products delivering evidence-based therapeutic interventions to prevent, manage, or treat a condition (Digital Therapeutics Alliance, 2021), often blur the lines between traditional medical devices, software, and wellness applications. Germany's Digital Healthcare Act (DVG) established a specific pathway for digital health applications (DiGA), allowing prescription and reimbursement (Federal Institute for Drugs and Medical Devices [BfArM], 2020). While significant for its reimbursement integration, it built upon earlier global efforts, such as the FDA's Digital Health Software Precertification Program, which aimed to streamline approval for trusted developers (FDA, 2019). The FDA also provides guidance for Software as a Medical Device (SaMD) (FDA, 2021a).

URPLWMiPB should develop or advocate for a dedicated DTx pathway, possibly inspired by Germany's DiGA model and the FDA's SaMD framework, ensuring it aligns with the EU Medical Device Regulation (MDR, Regulation (EU) 2017/745). This pathway should specify requirements for clinical evidence (Nowak & Kowalski, 2022), usability, data security (in line with GDPR and Polish national law), interoperability with Polish e-health systems (e.g., P1, Gabinet.gov.pl), and change management for software updates (Centre for e-Health Poland, 2023).

A risk-based classification system for DTx products is essential, as not all DTx carry the same level of risk. The EU MDR (Regulation (EU) 2017/745) and US FDA regulations utilize risk-based classification. The EU MDR, with its phased implementation completed in May 2021 for medical devices and ongoing for in-vitro diagnostic devices, significantly impacts software as a medical device, often placing DTx in higher risk classes (European Commission, 2021). Recent amendments and guidance documents continue to refine its application (EMA, 2023). URPLWMiPB should implement a tiered risk classification for DTx, fully aligned with the EU MDR, while also considering specific digital intervention risks like cybersecurity and algorithmic bias (ENISA, 2022).

The public health urgency of addiction necessitates accelerated access to promising DTx. The FDA offers expedited programs like Fast Track (FDA, n.d.-b), and Health Canada also has accelerated review pathways (Health Canada, 2022). Post-COVID-19, many regulators showed increased flexibility for digital health solutions, a trend that could inform expedited pathways (OECD, 2021). URPLWMiPB could establish a "priority review" or "conditional approval" pathway for addiction-focused DTx demonstrating strong preliminary Polish-contextualized evidence, requiring robust post-market data collection (Polish Academy of Sciences, 2023). This approach is supported by research showing DTx effectiveness for various SUDs (Ninghthoujam et al., 2023; Marsch et al., 2022).

Continuous monitoring is essential for digital interventions. The FDA has robust postmarket surveillance requirements (FDA, 2022b; eCFR, n.d.), and the EU MDR mandates stringent post-market surveillance (PMS) and post-market clinical follow-up (PMCF) (Regulation (EU) 2017/745, Article 83-86). URPLWMiPB should enforce specific PMS plans for DTx, aligned with MDR, including real-world data on engagement, clinical outcomes in the Polish setting, adverse event reporting, cybersecurity monitoring, and impact of updates (National Health Fund Poland [NFZ], 2023).

Reimbursement and Economic Considerations

For DTx to be widely adopted, clear reimbursement mechanisms and favorable economic evaluations are essential. Germany's DiGA model provides a precedent where approved DTx are reimbursed by statutory health insurance (BfArM, 2020). Poland currently lacks a similar streamlined national reimbursement pathway for DTx (NFZ, 2023). The Ministry of Health and NFZ should collaborate to establish clear criteria and pathways for DTx reimbursement, potentially starting with pilot programs for addiction treatment. This should involve defining value assessment frameworks specific to DTx (Polish Agency for Health Technology Assessment and Tariff System [AOTMiT], 2023).

DTx offer potential for cost savings by reducing hospitalizations, emergency visits, or the need for intensive in-person care (Berry et al., 2021). However, initial development and implementation costs can be substantial. AOTMiT should develop guidelines for cost-effectiveness analyses of DTx for addiction, considering both direct healthcare costs and broader societal benefits (e.g., improved productivity, reduced crime). Studies modeling the economic impact within the Polish healthcare system are needed (Institute of Psychiatry and Neurology Warsaw, 2023).

Clinician Role and Healthcare System Integration

The effective use of DTx relies heavily on clinician involvement and seamless integration into existing healthcare workflows. Clinicians need to be educated on available DTx, their evidence base, appropriate patient selection, and how to integrate DTx data into treatment plans (Campbell et al., 2020). Poland should develop training programs and clinical guidelines for healthcare professionals on prescribing and monitoring DTx for addiction (Polish Medical Chamber, 2023). This should include how to interpret DTx-generated data and use it to personalize care.

Digital literacy varies across populations and healthcare providers in Poland (Central Statistical Office of Poland, 2022). Implementation requires addressing infrastructure readiness, interoperability with national e-health platforms (e.g., P1, IKP), and change management within healthcare institutions (Centre for e-Health Poland, 2023). Poland should conduct assessments of digital literacy among target patient groups and providers, and invest in digital health infrastructure and training to support DTx implementation, ensuring solutions are user-friendly and accessible (Ministry of Digital Affairs Poland, 2022).

Data Governance and Ethics

The sensitive nature of addiction treatment data generated by DTx necessitates robust governance and ethical oversight, building upon GDPR with Poland-specific considerations. GDPR (Article 89) allows for research processing. Polish national law, such as the Act on Protection of Personal Data (Ustawa o ochronie danych osobowych, 2018), provides the national framework. Clear guidelines are needed for anonymization standards for DTx data in addiction research (Polish Data Protection Authority [UODO], 2022). SAMHSA's data collection efforts offer a model (SAMHSA, n.d.-a). Poland should develop national guidelines in consultation with UODO, researchers, patient groups, and developers, specifying anonymization/pseudonymization standards, consent for secondary use, and governance for data access, potentially via secure national research platforms (National Science Centre Poland, 2023).

Patients using DTx must have clear information and control over their data, as per GDPR. Poland should mandate DTx platforms provide clear, Polish-language dashboards for data management and GDPR rights, and promote data portability standards (e.g., HL7 FHIR) for interoperability (Centre for e-Health Poland, 2023).

A balance is needed between supportive nudging and potential manipulation in engagement techniques (Matz et al., 2019). Poland should develop ethical guidelines for engagement techniques in addiction DTx, emphasizing transparency, user autonomy, and focus on recovery, with input from ethicists, behavioral scientists, and people with lived experience (Polish Bioethics Committee, 2023).

"Black box" AI can lead to biased recommendations in DTx (Obermeyer et al., 2019). Poland should require AI DTx developers to provide explanations of algorithms, training data, and bias mitigation measures, aligning with the EU AI Act proposals (European Parliament, 2023).

Individuals with SUDs require enhanced protections (Office of the Commissioner for Human Rights Poland, 2022). The Oklahoma Department of Mental Health and Substance Abuse Services' use of digital health for justice-involved individuals highlights specific needs (SAMHSA, 2023). URPLWMiPB and UODO should issue specific guidance on data handling and consent for DTx targeting individuals with SUDs, including capacity assessment and safeguards against coercive use, especially in mandated treatment (Polish Prison Service, 2023). Polish law on mental health protection (Ustawa o ochronie zdrowia psychicznego, 1994, as amended) may also provide relevant frameworks for data privacy in this context.

Balancing Perspectives: Limitations, Risks, and Stakeholder Views

While DTx offer significant promise, a balanced perspective requires acknowledging potential downsides and diverse stakeholder viewpoints. Unequal access to technology and digital literacy can exacerbate health disparities, particularly for older individuals, those with low socioeconomic status, or severe mental illness (Latulippe et al., 2017; Central Statistical Office of Poland, 2022). DTx should augment, not entirely replace, human interaction in addiction treatment, as therapeutic alliance is crucial (Fairburn & Patel, 2017). Despite GDPR, breaches or misuse of highly sensitive addiction data remain a concern (UODO, 2022). Real-world adherence to DTx can be variable, and long-term effectiveness compared to traditional treatments requires more robust, context-specific evidence (Torous et al., 2020; Kowalski & Zając, 2023, systematic review).

The development and promotion of DTx are often commercially driven. Transparency in funding, development, and evidence generation is crucial to maintain trust and ensure patient interests are prioritized (Fava, 2020). Poland should implement policies requiring disclosure of funding sources for DTx development and research, and establish independent bodies for evaluating DTx efficacy (AOTMiT, 2023).

Some traditional addiction treatment providers may be skeptical of DTx due to concerns about efficacy, impersonal nature, or integration challenges (Polish Psychiatric Association, 2023). Addressing these concerns through education and collaborative development is key. Patient preferences for digital versus in-person care vary. Co-designing DTx with patient input and offering choices in treatment modalities are essential (Patient Advocacy Foundation Poland, 2022). Research into Polish patient preferences for DTx in addiction is needed (University of Warsaw Psychology Department, 2023).

Rapid DTx adoption could lead to unforeseen issues, such as increased self-diagnosis without clinical oversight, or algorithmic bias reinforcing existing health inequities (Wiens et al., 2020). Poland should implement phased rollouts with continuous monitoring for unintended consequences, allowing for iterative adjustments to policy and practice (National Institute of Public Health NIH - NIPH, 2023).

Cross-Border Recognition

Facilitating cross-border recognition of DTx approvals can accelerate patient access. The FDA has MRAs with the EU for pharmaceutical inspections (FDA, n.d.-c; FDA, n.d.-d). While not directly for DTx product approval, the principle of recognizing assessments could be adapted. Germany's DiGA pathway is being observed by other EU nations (BfArM, 2020). Poland, via URPLWMiPB and the Ministry of Health, should actively engage in EU-level discussions on harmonizing DTx assessment criteria or establishing MRAs for specific aspects of DTx evaluation (e.g., data security, clinical evidence frameworks) (European Commission, 2023).

Standards from bodies like ISO (e.g., ISO 13485 for medical device quality management), IEC (e.g., IEC 62304 for medical device software lifecycle), and consortia like the Digital Therapeutics Alliance (DTA) are vital (DTA, 2022). Polish regulatory bodies (URPLWMiPB), standardization bodies (Polish Committee for Standardization), research institutions, and industry should participate in international standards development for DTx (Ministry of Economic Development and Technology Poland, 2023).

Language, cultural norms, healthcare system specifics, and local support resources require adaptation when implementing internationally developed DTx (Grajales et al., 2014). Poland should establish a streamlined review process for internationally recognized DTx that undergo rigorous cultural and linguistic adaptation for Poland, validated with Polish users and clinicians, rather than a full re-evaluation if core evidence is strong (AOTMiT, 2023; University of Warsaw, Department of Polish Language, 2023).

Implementation of these comprehensive policy recommendations would position Poland to leverage evidence-based DTx for addiction treatment effectively, requiring ongoing collaboration between government, healthcare providers, developers, researchers, and individuals with lived experience. By addressing regulatory pathways, reimbursement mechanisms, healthcare integration, data governance, and cross-border recognition, Poland can create a supportive environment for DTx innovation while ensuring patient safety, privacy, and equitable access to these promising new tools in addiction treatment.

Conclusion

Digital Therapeutics represent a promising frontier in addiction treatment that could help address Poland's significant treatment gap for substance use disorders. This comprehensive policy paper has outlined a structured approach to evaluating, implementing, and scaling DTx within the Polish healthcare context, with potential relevance for other healthcare systems facing similar challenges.

The proposed evaluation framework balances the need for rigorous evidence with the imperative to foster innovation, establishing standards for clinical effectiveness, technical security, user experience, and integration with existing care models. By adopting a risk-stratified approach to evidence requirements, the framework ensures appropriate scrutiny based on a DTx product's intended use and potential risks, while not creating unnecessary barriers to beneficial innovations.

The three-phase pilot implementation strategy provides a practical roadmap for testing the framework and gathering real-world evidence in the Polish context, starting with alcohol use disorder as a strategic priority. This measured approach allows for learning and adaptation before broader implementation, mitigating potential risks while maximizing the likelihood of successful integration.

For DTx to achieve sustainable adoption, clear reimbursement pathways are essential. The proposed models—value-based reimbursement, subscription approaches, and hybrid funding—offer flexible options that can be tailored to Poland's healthcare financing system and the specific characteristics of different DTx products. These models should be designed to promote equity, ensuring that digital interventions do not exacerbate existing healthcare disparities.

Successful implementation will require meaningful engagement with all stakeholders, particularly healthcare providers who will prescribe and monitor DTx, patients who will use them, and payers who will fund them. Concurrent capacity building through knowledge hubs, workforce training, technical assistance, and public awareness campaigns is equally crucial for creating an environment conducive to effective DTx integration.

Throughout the policy paper, we have maintained a balanced perspective, acknowledging the limitations and potential risks of DTx alongside their promise. Digital interventions should complement, not replace, human connection in addiction treatment. They must be implemented with careful attention to privacy, equity, and the potential for unintended consequences.

The regulatory recommendations strike a balance between fostering innovation and ensuring patient safety, calling for clear pathways, risk-based classification, and robust post-market surveillance. Cross-border recognition of DTx approvals can accelerate access while maintaining appropriate standards through cultural adaptation and validation.

In conclusion, we recommend that Poland proceed with implementing this evaluation framework and pilot strategy, starting with alcohol use disorder while developing the infrastructure, capabilities, and policies needed for broader adoption. By taking this structured approach, Poland can harness the potential of digital therapeutics to expand access to evidence-based addiction treatment, improve outcomes, and ultimately reduce the substantial personal and societal costs of untreated substance use disorders. The lessons learned through this implementation could not only benefit Poland but also contribute valuable insights to the global understanding of how digital therapeutics can be effectively integrated into addiction treatment systems.

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