Accessibility and equity considerations in the clinical validation of prescription digital therapeutics: a scoping review

Introduction

Digital health products are often cited as a potential mechanism for expanding equal access to high-quality healthcare services and reducing health disparities. It is imperative that these tools are developed using a health equity lens to ensure these improvements are accessible and beneficial to all populations.

Digital therapeutics (DTx) are software-based digital health products that are classified by the Food and Drug Administration (FDA) as Software as a Medical Device (SaMD) or Mobile Medical Applications (MMA). The development of DTx typically follows a structured approach that includes the identification of a clinical need, software development, and rigorous clinical validation to ensure safety and efficacy. The Digital Therapeutics Alliance (DTA) has established a set of best practices for the development and deployment of DTx, focusing on patient-centered design, usability, and evidence-based validation. However, these guidelines are not mandatory and may not fully address the specific needs of culturally and linguistically diverse populations. Accessibility and equity considerations may be crucial for DTx because the effectiveness of the therapeutic intervention is dependent on the patient independently and consistently utilizing the software. Current FDA policy does not require cultural competence or linguistic diversity assessments for medical devices submitted to the agency for approval (1). The FDA has non-binding recommendations promoting diversity, but a recent review found that less than 30% of submissions to the FDA for premarket approval reported diversity data (2). Medical devices are not subject to the National Standards for Culturally and Linguistically Appropriate Services (CLAS) that are designed to ensure that patients from racial, cultural, and language minority communities have equal access to high quality health services (3).

To this end, research shows that digital health interventions are largely less accessible to and less effective for racial, ethnic, and culturally minoritized groups, even after controlling for factors such as socioeconomic status, place of residence, and education level (4,5). Psychosocial interventions are underpinned by the sociocultural context of their development; in most cases that of White males from the West. The disparity in the effectiveness of these interventions for cultural/ethnic minority populations can be partially attributed to differences in cultural values and beliefs between Western and non-Western communities. This impact is compounded for DTx because there is no clinician involvement, and therefore no opportunity for individual tailoring that could carry dimensions of culture into the intervention. Studies have shown that the lack of culturally appropriate tailoring can produce treatment gaps between Black and White patients, lead to decreased health utilization for patients of color, and create community mistrust of the healthcare system (6,7).

Technological access and digital literacy represent the emerging digital determinants of health (8). DTx are largely designed and developed in cultural contexts where technology access and digital literacy are ubiquitous, and therefore may not consider the barriers for populations who are impacted by the digital divide (5,8). DTx and other digital interventions that require technological tools are inaccessible to populations who do not have or know how to use these tools. Low-income, rural, and racial/ethnic minority populations are more likely to lack technology access and digital literacy, which exacerbates existing health disparities associated with the social determinants of health.

To our knowledge this is the first review of health equity, cultural competence, or digital access factors for currently marketed prescription DTx. This review focuses on assessing evidence reported in FDA-mandated clinical validation studies. These studies are conducted specifically to establish the safety and efficacy of the product under evaluation for the intended use population which makes them particularly appropriate for the assessment in a scoping review.

The intent of the scoping review was to examine the extent, range, and nature of research activity related to health equity, cultural competence, and digital accessibility considerations in the development of prescription digital therapeutic products. Health equity, cultural competence, and digital access factors must be considered in the design, development, and validation processes of DTx to ensure these products achieve their intended results for the entire intended use population. We present this article in accordance with the PRISMA-ScR reporting checklist (available at https://mhealth.amegroups.com/article/view/10.21037/mhealth-25-12/rc).

Methods

Research question

The review was conducted following the methodological framework proposed (9) and updated by prior research (10), which guided the systematic identification, selection, and synthesis of relevant literature on DTx. The review was guided based on the research question: “Are the prescription digital therapeutics currently on the market appropriate for culturally and linguistically diverse populations?” This question was refined iteratively through group discussions with the research team to ensure it was broad enough to capture relevant studies while maintaining focus on the specific concerns related to health equity, cultural competence, and digital access. Identified literature was assessed to identify product or clinical trial design considerations relevant to health equity, cultural competence, and digital accessibility, and data enabling the assessment of the effects of the intervention on health equity. We did not have a review protocol since we utilized an iterative process for this exploratory scoping review.

Eligibility criteria

Products were included if they received FDA authorization through the end of 2023. The search covered studies published up until February 2023 that were relevant to products which received FDA authorization in 2023 or earlier. The eligibility criteria for the inclusion of articles in this review were as follows: articles were considered if they were case reports describing the use of the subject device or human clinical studies presenting clinical evidence on the subject device. Articles were excluded if they were duplicate publications, did not constitute clinical studies or case reports (for example, in vitro, animal, cadaver, benchtop, or biomechanical studies, patents), were not pertinent to the subject device, primarily focused on health economic evaluations, or primarily contained duplicate data from another included study. These references were included in the clinical evidence assessment. In these cases, the results posted on ClinicalTrials.gov were included in the clinical evidence assessment. Evaluations of predicate technologies relevant to the development of the devices in scope were also included when this information was available.

Information sources

Data on authorized therapeutic applications was extracted from the FDA Product Code Classification Database (11) using a procedure adapted from past research (12). Identified product labelling and regulatory approval documents were manually searched for references to clinical literature. To enhance the results beyond the references specifically included in the FDA documentations, PubMed, Google Scholar, and ClinicalTrials.Gov were searched for the product name, manufacturer, and known previous product names (e.g., “Regulora”, “MetaMe Health”). The included articles’ reference lists were hand searched for relevant publications. The most recent search was executed in March 2023.

Search

This involved searching the FDA database by (I) using the terms “digital”, “mobile”, “software”, “application”, “smartphone”, and “computer”; and (II) excluding product codes that were not therapeutic in functionality or were not software-only devices. The resulting product codes were inputted into the FDA Center for Devices and Radiological Health approved product database to identify DTx products. The literature search focused on four key domains: health equity considerations, cultural competence in design and implementation, digital accessibility, and clinical effectiveness, as it relates to clinical evidence of identified prescription DTx. The primary intention of this review was to review clinical evidence used in the development and submission of the DTx products for FDA approval. Given the focus on FDA-mandated validation studies for specific commercially available products, this targeted search approach was deemed appropriate for capturing the relevant clinical evidence used in regulatory submissions. There were two instances where the clinical trial listings included results from clinical evaluations that were not identified in the published clinical literature.

Selection of sources of evidence

All citations were imported into the bibliographic manager Zotero and duplicate citations were removed manually. Level one (title and abstract) and level two (full text) screening were conducted and tracked in an Excel spreadsheet using Covidence Review software to ensure the quality of our search results. The initial screening was performed by [Redacted Initials], followed by a comprehensive review of the full texts of the selected papers.

Data charting process

Data extraction followed a systematic approach, with a comprehensive data extraction form developed based on the guidelines in the Cochrane Handbook for Systematic Reviews of Interventions. The data extraction form included standardized definitions and assessment criteria for health equity factors, cultural competence evaluations, and digital literacy assessments to ensure consistent application across all studies. The data extraction form was reviewed and approved by all investigators. Data extraction was performed in Excel by one investigator and verified through a thorough, independent review by a second investigator ([Redacted Initials]), with discrepancies resolved through discussions with a third reviewer ([Redacted Initials]) until consensus was achieved. Discrepancies between reviewers were systematically documented and categorized by type (factual extraction errors versus interpretive differences in assessment ratings). Disagreements were first addressed through discussion between the two primary reviewers, with reviewers referring back to the operational definitions. When consensus could not be reached after discussion, a third reviewer ([Redacted Initials]) provided an independent assessment of the disputed items. Final decisions were made by majority consensus among the three reviewers, with all resolution decisions documented along with the rationale for the final determination.

Data items

The following details were extracted from each included study: publication details (title, journal, and year); authors’ details (names, affiliations, funding, and conflicts of interest); study details (start and end date, country, design, purpose, and statistical analyses); participant’s characteristics (condition, inclusion and exclusion criteria, sample size, recruitment process, and demographics); intervention (type, duration, frequency, other details, and primary and secondary outcome); results (primary and secondary outcomes). Each study was assessed for the incorporation of health equity considerations using the PROGRESS-Plus framework, which includes factors such as place of residence, race/ethnicity, culture/language, occupation, gender/sex, religion, educational background, socioeconomic status, and social capital. For this review, ‘race/ethnicity’ and ‘culture/language’ were considered separately, and LGBTQ+ identity was added as a distinct category. Each article was also assessed for methodology used to assess effects of health inequalities (e.g., subgroup analysis, targeted analysis of vulnerable populations) and reference to health equity factors in the study discussion, limitations, or implications.

Studies were evaluated for cultural appropriateness using a systematic assessment framework with operationally defined criteria. Cultural adaptation was assessed based on: (I) whether studies employed evidence-based cultural adaptation frameworks, defined as peer-reviewed systematic approaches for modifying interventions for specific cultural groups (e.g., Bernal & Sáez-Santiago Cultural Adaptation Framework, Cultural Adaptation Process model by Cabassa & Baumann, or similar validated frameworks); and (II) whether studies addressed researchers’ cultural biases by explicitly acknowledging potential cultural limitations in study design, discussing cultural assumptions underlying interventions, or recognizing cultural factors that may influence intervention effectiveness. Studies were also evaluated for any reference to cultural competence or cultural adaptation in the study discussion, limitations, or implications sections.

Linguistic appropriateness was assessed using standardized criteria: (I) availability of intervention materials in languages other than English, with documentation of which languages were offered; and (II) inclusion of systematic translation and cultural adaptation processes for individuals with limited English proficiency, including back-translation procedures, cultural review panels, or community input processes. Studies were systematically reviewed for explicit language-based exclusion criteria and documentation of participants’ primary or preferred languages.

Studies were systematically reviewed for digital access and literacy using operationalized criteria adapted from prior research (13). Each criterion was assessed using standardized definitions: (I) baseline digital literacy was considered adequately assessed if studies evaluated participants’ ability to use smartphones for basic functions like chatting, reading, and writing, or assessed prior technology experience and comfort levels; (II) appropriate device/software training was rated as adequate if studies provided structured patient training and guidance on technology use, including orientation protocols or documented training procedures; (III) reading level appropriateness required assessment of content using plain language principles, avoidance of medical jargon, or explicit evaluation of health literacy considerations; (IV) health-related content language was evaluated for display and organization of information with simplified navigation, clear visual design, and intuitive user interfaces; and (V) device and software usability required formal usability testing, feasibility studies, or systematic user experience evaluation conducted before or during implementation. Additionally, the context surrounding technological access for the intended populations was reviewed. Compatibility with digital accessibility tools was systematically extracted and categorized as: (I) screen reader compatibility; (II) text size enhancement options; (III) text-to-speech functions; and (IV) other accessibility accommodations (high contrast modes, keyboard navigation, etc.).

Synthesis of results

We did not reach out to study authors for additional or unclear information. Given the anticipated variability in tasks and endpoints, we did not perform formal meta-analyses. Instead, we provided aggregate statistics to offer an overview of the characteristics of the eligible trials. The data was then organized into thematic categories based on health equity, cultural competence, and digital access, allowing for the identification of patterns and gaps.

Results

Four relevant product codes were identified from the FDA Product Code Database search (Table 1 and Figure 1). The product search identified seven FDA cleared DTx products (Table 2 and Appendix 1). There were 32 clinical studies identified in the clinical evidence search (Figure 2). Of these, 25 studies pertained to the devices under evaluation or a precursor device. Precursors were defined as versions of the device with the same intended purpose and for the same intended use population that were delivered through digital mechanisms different than those in the final version of the device (e.g., web-based vs. mobile app). Precursor technologies were included if they were referenced in the FDA approval documentation and relevant literature was identified through the clinical evidence search. These studies are described in Table 3.

Figure 1 FDA product code database search results. FDA, Food and Drug Administration.

Figure 2 PRISMA diagram. ^a, one [1] article for reSET could not be located (Exp Clin Psychopharmacol 2000;3:205-2). This reference was found in the FDA De Novo summary in the manufacturer-provided device description (De Novo Summary-DEN160018, 2017). No information about the article title or author(s) was found in the document. The ‘Device Description’ section states that reSET is based on a specialized version of CBT called the CRA and includes in-line citations for two [2] articles purportedly describing the development of CRA. The third issue of the 2000 volume of the Journal of Experimental Clinical Psychopharmacology does not include the listed pages (pp. 205 to 212). The abstracts for all articles published by the journal in 2000 were screened but none [0] were relevant to the CRA approach of CBT. The other article referenced in the ‘Device Description’ was located and is included in the evidence assessment (Hunt & Azrin, 1973). ^b, there was some overlap in articles identified for reSET and reSET-O, likely due to the commonalities in the intervention, development, and manufacturer for these products. These products are differentiated by their intended use population; reSET is indicated for patients with (non-opiate) substance use disorder whereas reSET-O is indicated for patients with opioid use disorder. reSET is identified as a predicate device for reSET-O. For the purposes of this review, studies that included only opioid-dependent patients were classified as pertaining to reSET-O and all other studies were classified as pertaining to reSET. ^c, one [1] article reported results of two [2] separate studies; these studies were assessed separately (Palsson et al., 2002). CBT, cognitive-behavioral therapy; CRA, community reinforcement approach; FDA, Food and Drug Administration.

Seven of the identified studies pertained to non-digital evidence-based therapeutic models that underlie the therapeutic intervention delivered by the devices under evaluation. Information about the underlying therapeutic models was included if they were referenced in the FDA approval documentation and relevant literature was identified through the clinical evidence search. These studies are described in Table 4. The therapeutic intervention for EndeavorRx is a video game-like software that was developed and validated for current use in digital format, so there is no applicable therapeutic-model. Somryst implements a model of cognitive behavioral therapy (CBT) for insomnia. The regulatory approval documents and labeling for this product reference pre-existing internet-based CBT-I programs which are included in Table 3.

The identified literature was assessed across the themes of health equity, cultural and linguistic appropriateness, and digital literacy and digital access. All 32 studies were included in the health equity and cultural and linguistic appropriateness assessments. Seven studies that did not involve use of a digitally delivered intervention were excluded from the digital access and digital literacy evaluation; therefore, the assessment for these categories is based on 25 studies.

Across the 32 included studies, the most reported PROGRESS-Plus factors were gender (n=31), race/ethnicity (n=22), and educational status (n=21) (Figure 3). Subgroup or differential effects analyses for PROGRESS-Plus factors were reported in 13 studies; three of which found significant differences. Two studies, both for Mahana (14,15), used the English Indices of Deprivation to characterize the relative deprivation level of the participants’ primary place of residence. Both studies found that participants residing in more deprived areas were less likely to experience symptom reduction after completing web-delivered CBT for irritable bowel syndrome (IBS). One study for Regulora (16), found the hypnosis treatment was more effective for females than males.

Figure 3 Reporting and assessment across PROGRESS-Plus factors (n=32). LGBTQ, lesbian, gay, bisexual, transgender and queer.

No studies reported data related to the participants’ religious status or background. One study reported data related to LGBTQ+ status; this study enrolled a single participant identifying as transgender/gender nonconforming (17). Notably, this study was a qualitative usability and patient preference assessment of reSET which did not involve use of the device. One study for reSET was conducted in a prison setting with a population of incarcerated individuals who were nearing release from the facility.

Occupation was not applicable for seven of the 32 included studies because they were for EndeavorRx, which is indicated for pediatric use. All ten studies that reported occupation data limited this information to occupation status (e.g., employed full-time, employed part-time, unemployed, etc.); none reported type of occupation or profession.

The articles included in this review did not describe any cultural adaptation, either in their own design and development process or by reference to existing evidence-based cultural adaptation frameworks. There was no evidence that the researchers designing the interventions assessed for their own cultural biases or assessed how patients’ culture, language, or religion could impact interventional appropriateness or effectiveness. Five of the six products referenced existing evidence-based interventions as the basis for the model of therapy delivered by the DTx; none of which reference cultural competence or cultural adaptation. Four of the six products are available in English only, with no identified processes for translation and adaptation for individuals with limited English proficiency. Fifteen studies in this review also explicitly excluded participants who were not fluent in English and no studies included data about participants’ primary or native languages.

A ClinicalTrials.Gov listing (NCT05353296) for Somryst indicates that validation of a culturally adapted Spanish language version of the product was initiated in 2022. The study was terminated after enrolling only 7 of 200 anticipated subjects and no associated publications were identified. A 2022 press release from Pear Therapeutics indicated that reSET and reSET-O were available in Spanish. However, no clinical evidence regarding the translation and adaption of the products has been identified in the scientific literature. Further, Pear Therapeutics filed for bankruptcy and its products were subsequently withdrawn from the market.

Two studies, both for Somryst (18,19), assessed the effect of digital literacy on interventional effectiveness and found participants’ self-reported level of comfort with internet use to have a statistically significant mediating effect on the effectiveness of the intervention. Digital literacy considerations of reviewed articles are shown in Figure 4.

Figure 4 Digital literacy considerations by study (n=32).

Technological access must be considered in the context of the intended use populations (Figure 5). reSET and reSET-O are intended for use by individuals with substance-use disorder and opiate-use disorder, respectively. These populations are often affected by houselessness and poverty, which limits their consistent access to reliable internet services. The clinical validation trials for these products involved participants using study-provided computer labs to access the investigational software during regularly scheduled medical appointments. This cannot be translated to real-world use of the products and none of the studies for these products reported the population’s baseline digital access. Similarly, children enrolled in the clinical trials for EndeavorRx were provided a tablet to use during the study, but in real-world application patients must have access to their own device which limits the use population to those who can afford these devices. None of the studies related to EndeavorRx described the population’s baseline digital access or assessed for digital literacy.

Figure 5 Digital access across clinical studies (n=32).

Products were also assessed on general accessibility. Clinical studies for reSET and reSET-O indicate that participants had the option to have the content of the intervention read aloud by the computer via text to speech. It is unclear if this feature is available in the commercially available version of the product which is mobile-app based, whereas the version used in these studies was computer-based. No information was found regarding compatibility with other digital accessibility tools for the other products in scope.

Discussion

The results of this scoping review indicate that there is a consistent deficit in assessing the appropriateness and effectiveness of DTx across health equity, cultural competence, and digital access domains. More than 60% of studies reported population characteristics for gender, race/ethnicity, and education level. However, less than 15% of studies reported other characteristics related to health equity. There was no data for any product regarding cultural and linguistic appropriateness and none are accessible for individuals with limited English proficiency. The two studies that assessed the effect of digital literacy on interventional effectiveness both found a statistically significant mediating effect (18,19). These results are supported by a review (20), which found that digital literacy was a critical factor influencing the uptake and effectiveness of DTx by both patients and health professionals. Their work similarly highlighted that while demographic characteristics like age, gender, and ethnicity were frequently considered in patient-related discussions, other factors such as digital literacy were underreported, despite being identified as the most important factor by health professionals.

Clinical evidence for reSET and reSET-O included acknowledgement of the particular accessibility and cultural challenges for the target patient population, however, the operationalization of these considerations was lacking across all included studies and particularly in the studies regarding the underpinning therapeutic model. Studies for 2 of the 3 products (Mahana and Regulora) intended for patients with IBS included some considerations of the participants’ demographic characteristics. Studies for EndeavorRx included very limited information about accessibility and equity; however, the therapeutic model underpinning this product is neurological rather than behavioral in nature which may inherently reduce the impact of these disparities.

None of the products included in the review reported considerations related to cultural competence or linguistic appropriateness. There were no references to evidence-based cultural adaptation frameworks and no products are available in non-English languages. This was despite the fact that 5 out of 6 reviewed Dtx products were based on existing evidence-based psychological or behavioral health interventions. These findings are particularly striking, as they reveal a fundamental gap in the lack of consideration for cultural factors in the original conception of the interventions these DTx are based upon. While this is the first study that has reviewed literature on the cultural and linguistic accessibility of DTx, other reviews focused on health interventions more broadly have found similar trends. A previous review (21) found that across 200 cluster and randomized clinical trials, only 9% of studies reported subgroup analyses by age/ethnicity/culture/language, 4% by socioeconomic status, 3% by place of residence, and less than 5% cumulatively for all other PROGRESS-Plus characteristics (21). Similarly, a review of medical device clinical trials found that only 14% provided subgroup analyses that addressed both effectiveness and safety, or sensitivity and selectivity, across gender, race, and age (2).

Unlike traditional medical devices like oxygen therapy, which work through proper use under supervision, DTx rely on patient engagement, motivation, and adherence to achieve therapeutic outcomes. The CLAS Standards in Health Care, which guides healthcare organizations in ensuring their services are responsive to the cultural and linguistic needs of diverse patient populations, are commonly implemented in hospitals via translated patient education materials or culturally tailored mental health services (22). These standards, however, do not currently apply to medical devices (13). While cultural and linguistic appropriateness may be less critical for traditional medical devices, which tend to function relatively independently of patient engagement, the engagement-driven nature of digital therapeutic interventions suggests that as these technologies become more prevalent, it is crucial to update existing standards to ensure they are equally engaging and effective for all users (23).

The FDA issued an Enforcement Policy in April 2020 that allowed the distribution and use of digital health therapeutic medical devices for mental health and psychiatric disorders without the requirement that these products comply with traditional regulatory policies (6). This guidance expired in November 2023 and as of 2024, any new DTx products must fully comply with all standard FDA regulatory requirements. Nonetheless, several federal policies and initiatives exist that aim to enhance access to digital technologies, particularly among underserved populations. The Digital Equity Act, part of the Infrastructure Investment and Jobs Act of 2021, was a federal policy that allocated $2.75 billion of federal funding to expand broadband access in rural and low-income areas and promote digital literacy training through community-based programs in schools and libraries (23).

However, while these initiatives improve access and useability of digital products and therapeutics, they may not be sufficient for racially and ethnically diverse populations which often face unique cultural and linguistic barriers. While the FDA has issued nonbinding guidances encouraging diversity in clinical trials, these efforts have largely focused on drugs and biologics, with less attention to devices such as DTx. Historically, digital health regulation has emphasized innovation and market access over equity, leaving gaps in guidance around cultural competence, linguistic accessibility, and digital literacy. One solution could involve incorporating requirements for cultural and linguistic appropriateness into the FDA approval process for DTx, similar to the CLAS Standards in other healthcare areas or the FDA’s current mandate of Diversity Action Plans in clinical trials. Furthermore, streamlined processes could be developed for the approval of multilingual versions of DTx products, ensuring that non-English-speaking populations have timely access to these interventions. Finally, incentivizing the development of DTx that address health disparities, such as extended market exclusivity or fast-track approvals, could further encourage the creation of more inclusive digital health solutions. To ensure equitable effectiveness, future regulatory frameworks must explicitly incorporate health equity requirements into the clinical validation and FDA approval processes for DTx.

In addition to various federal initiatives, key frameworks have also been created to better incorporate digital equity in the development of DTx. The Patient-Centered Outcomes Research Institute (PCORI) Framework aims to include lived experiences from target populations during the development of health treatments, which has been shown to improve the recruitment and effectiveness of health interventions in underserved groups (24). Similarly, frameworks like the Framework for Digital Health Equity (FDHE) focus on enhancing consideration of social determinants of health such as socioeconomic status, education, and access to technology in the design and deployment of digital health tools (25).

There are several limitations for this review. First, this is a scoping review and may not include all the available evidence for these products. This limitation was mitigated to the extent possible by hand searching regulatory approval documents, product labeling, and the reference lists of the included articles, but it is still possible that some existing articles were not identified through this method. Additionally, our review was limited to prescription DTx that received FDA authorization through the end of 2023, which means that more recently approved products and their associated clinical evidence fall outside our scope. This temporal boundary was necessary to ensure comprehensive analysis of the regulatory evidence available at the time of our review. Furthermore, the search does not capture more recent products past February 2023, which may affect the comprehensiveness of the findings. Finally, due to the rapidly changing nature of the field, while expert opinions from the authors were considered, the input from other external stakeholders were not sought out to prioritize a timely synthesis of evidence

This review found insufficient evidence to conclude whether DTx are effective for or acceptable to individuals from historically oppressed minoritized communities. To address the identified gaps, future studies on DTx should focus on including populations from underrepresented racial, ethnic, and linguistic groups. Furthermore, future development of DTx should aim to integrate cultural adaptation frameworks, have competently translated and culturally neutral interventions, and include lived experiences and patient partnership research from target populations. The current market exacerbates health disparities and limits access for vulnerable populations, but the evolving regulatory landscape presents an opportunity to address these issues. Addressing these barriers will be crucial for the long-term and widespread adoption of DTx.

Conclusions

In summary, our findings reveal that clinical validation studies of FDA-approved prescription DTx inadequately assess health equity, cultural competence, and digital accessibility factors. While basic demographics were commonly reported, comprehensive equity considerations were largely absent, with no studies incorporating cultural adaptation frameworks or linguistic translations. The significant mediating effect of digital literacy on intervention effectiveness, despite being rarely assessed, demonstrates the critical need for systematic equity evaluations in DTx validation. These gaps suggest that current regulatory approaches may perpetuate health disparities rather than achieve the equitable healthcare access that DTx promise to deliver.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the PRISMA-ScR reporting checklist. Available at https://mhealth.amegroups.com/article/view/10.21037/mhealth-25-12/rc

Peer Review File: Available at https://mhealth.amegroups.com/article/view/10.21037/mhealth-25-12/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://mhealth.amegroups.com/article/view/10.21037/mhealth-25-12/coif). S.D. is an employee of Smith and Nephew Inc. The other authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

References

1. Kelsey MD, Patrick-Lake B, Abdulai R, et al. Inclusion and diversity in clinical trials: Actionable steps to drive lasting change. Contemp Clin Trials 2022;116:106740. [Crossref] [PubMed]
2. Fox-Rawlings SR, Gottschalk LB, Doamekpor LA, et al. Diversity in Medical Device Clinical Trials: Do We Know What Works for Which Patients? Milbank Q 2018;96:499-529. [Crossref] [PubMed]
3. Whitehead L. Barriers to and Facilitators of Digital Health Among Culturally and Linguistically Diverse Populations: Qualitative Systematic Review. J Med Internet Res 2023;25:e42719. [Crossref] [PubMed]
4. Mitchell UA, Chebli PG, Ruggiero L, et al. The Digital Divide in Health-Related Technology Use: The Significance of Race/Ethnicity. Gerontologist 2019;59:6-14. [Crossref] [PubMed]
5. Saeed SA, Masters RM. Disparities in Health Care and the Digital Divide. Curr Psychiatry Rep 2021;23:61. [Crossref] [PubMed]
6. Friis-Healy EA, Nagy GA, Kollins SH. It Is Time to REACT: Opportunities for Digital Mental Health Apps to Reduce Mental Health Disparities in Racially and Ethnically Minoritized Groups. JMIR Ment Health 2021;8:e25456. [Crossref] [PubMed]
7. Brogan J. The Next Era of Biomedical Research: Prioritizing Health Equity in The Age of Digital Medicine. Voices in Bioethics 2021;7: [Crossref]
8. Sieck CJ, Sheon A, Ancker JS, et al. Digital inclusion as a social determinant of health. NPJ Digit Med 2021;4:52. [Crossref] [PubMed]
9. Arksey H, O’Malley L. Scoping studies: towards a methodological framework. International Journal of Social Research Methodology 2005;8:19-32.
10. Levac D, Colquhoun H, O'Brien KK. Scoping studies: advancing the methodology. Implement Sci 2010;5:69. [Crossref] [PubMed]
11. U.S. Food and Drug Administration. Product Code Classification Database. Retrieved January 3, 2023. Available online: https://www.fda.gov/medical-devices/classify-your-medical-device/product-code-classification-database
12. Ono M, Iwasaki K. Comprehensive Analysis of Clinical Studies and Regulations of Therapeutic Applications in the United States and Japan. Ther Innov Regul Sci 2023;57:86-99. [Crossref] [PubMed]
13. Birati Y, Yefet E, Perlitz Y, et al. Cultural and Digital Health Literacy Appropriateness of App- and Web-Based Systems Designed for Pregnant Women With Gestational Diabetes Mellitus: Scoping Review. J Med Internet Res 2022;24:e37844. [Crossref] [PubMed]
14. Everitt HA, Landau S, O'Reilly G, et al. Assessing telephone-delivered cognitive-behavioural therapy (CBT) and web-delivered CBT versus treatment as usual in irritable bowel syndrome (ACTIB): a multicentre randomised trial. Gut 2019;68:1613-23. [Crossref] [PubMed]
15. Everitt H, Moss-Morris R, Sibelli A, et al. Management of irritable bowel syndrome in primary care: the results of an exploratory randomised controlled trial of mebeverine, methylcellulose, placebo and a self-management website. BMC Gastroenterol 2013;13:68. [Crossref] [PubMed]
16. Miller V, Carruthers HR, Morris J, et al. Hypnotherapy for irritable bowel syndrome: an audit of one thousand adult patients. Aliment Pharmacol Ther 2015;41:844-55. [Crossref] [PubMed]
17. Glass JE, Matson TE, Lim C, et al. Approaches for Implementing App-Based Digital Treatments for Drug Use Disorders Into Primary Care: A Qualitative, User-Centered Design Study of Patient Perspectives. J Med Internet Res 2021;23:e25866. [Crossref] [PubMed]
18. Ritterband LM, Thorndike FP, Ingersoll KS, et al. Effect of a Web-Based Cognitive Behavior Therapy for Insomnia Intervention With 1-Year Follow-up: A Randomized Clinical Trial. JAMA Psychiatry 2017;74:68-75. [Crossref] [PubMed]
19. Christensen H, Batterham PJ, Gosling JA, et al. Effectiveness of an online insomnia program (SHUTi) for prevention of depressive episodes (the GoodNight Study): a randomised controlled trial. Lancet Psychiatry 2016;3:333-41. [Crossref] [PubMed]
20. van Kessel R, Roman-Urrestarazu A, Anderson M, et al. Mapping Factors That Affect the Uptake of Digital Therapeutics Within Health Systems: Scoping Review. J Med Internet Res 2023;25:e48000. [Crossref] [PubMed]
21. Petkovic J, Jull J, Yoganathan M, et al. Reporting of health equity considerations in cluster and individually randomized trials. Trials 2020;21:308. [Crossref] [PubMed]
22. Diamond LC, Wilson-Stronks A, Jacobs EA. Do hospitals measure up to the national culturally and linguistically appropriate services standards? Med Care 2010;48:1080-7. [Crossref] [PubMed]
23. Barksdale CL, Rodick WH 3rd, Hopson R, et al. Literature Review of the National CLAS Standards: Policy and Practical Implications in Reducing Health Disparities. J Racial Ethn Health Disparities 2017;4:632-47. [Crossref] [PubMed]
24. Federal Register. Digital Equity Act of 2021; Request for Comments. A Notice by the National Telecommunications and Information Administration on 03/02/2023. Available online: https://www.federalregister.gov/documents/2023/03/02/2023-04242/digital-equity-act-of-2021-request-for-comments
25. Fortuna KL, Myers A, Brooks J, et al. Co-production of the quality of patient-centered outcomes research partnerships instrument for people with mental health conditions. Patient Exp J 2021;8:148-56. [Crossref] [PubMed]
26. Richardson S, Lawrence K, Schoenthaler AM, et al. A framework for digital health equity. NPJ Digit Med 2022;5:119. [Crossref] [PubMed]
27. U.S. Food and Drug Administration. DEN200029 (November 25, 2020). Available online: https://www.accessdata.fda.gov/cdrh_docs/pdf20/DEN200029.pdf
28. U.S. Food and Drug Administration. K211372 (June 2, 2021). Available online: https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211372.pdf
29. U.S. Food and Drug Administration. K211463 (November 24, 2021). Available online: https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211463.pdf
30. U.S. Food and Drug Administration. De Novo Summary (DEN160018) (May 16, 2016). Available online: https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN160018.pdf
31. U.S. Food and Drug Administration. K173681 (May 23, 2019). Available online: https://www.accessdata.fda.gov/cdrh_docs/pdf17/K173681.pdf
32. U.S. Food and Drug Administration. K191716 (September 15, 2023). Available online: https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191716.pdf
33. U.S. Food and Drug Administration. DEN200026 (June 15, 2020). Available online: https://www.accessdata.fda.gov/cdrh_docs/pdf20/DEN200026.pdf
34. ClinicalTrials.gov. An exploratory study to assess the sustained effects of digital therapy in pediatric subjects 8 to 12 years old with attention deficit hyperactivity disorder (ADHD). Akili Interactive Labs, Inc. 2019-01-18. Available online: https://clinicaltrials.gov/ct2/show/NCT02828644
35. Anguera JA, Brandes-Aitken AN, Antovich AD, et al. A pilot study to determine the feasibility of enhancing cognitive abilities in children with sensory processing dysfunction. PLoS One 2017;12:e0172616. [Crossref] [PubMed]
36. Davis NO, Bower J, Kollins SH. Proof-of-concept study of an at-home, engaging, digital intervention for pediatric ADHD. PLoS One 2018;13:e0189749. [Crossref] [PubMed]
37. Gallen CL, Anguera JA, Gerdes MR, et al. Enhancing neural markers of attention in children with ADHD using a digital therapeutic. PLoS One 2021;16:e0261981. [Crossref] [PubMed]
38. Kollins SH, DeLoss DJ, Cañadas E, et al. A novel digital intervention for actively reducing severity of paediatric ADHD (STARS-ADHD): a randomised controlled trial. Lancet Digit Health 2020;2:e168-e178. [Crossref] [PubMed]
39. Kollins SH, Childress A, Heusser AC, et al. Effectiveness of a digital therapeutic as adjunct to treatment with medication in pediatric ADHD. NPJ Digit Med 2021;4:58. [Crossref] [PubMed]
40. Yerys BE, Bertollo JR, Kenworthy L, et al. Brief Report: Pilot Study of a Novel Interactive Digital Treatment to Improve Cognitive Control in Children with Autism Spectrum Disorder and Co-occurring ADHD Symptoms. J Autism Dev Disord 2019;49:1727-37. [Crossref] [PubMed]
41. Hughes S, Sibelli A, Everitt HA, et al. Patients' Experiences of Telephone-Based and Web-Based Cognitive Behavioral Therapy for Irritable Bowel Syndrome: Longitudinal Qualitative Study. J Med Internet Res 2020;22:e18691. [Crossref] [PubMed]
42. Jacobs JP, Gupta A, Bhatt RR, et al. Cognitive behavioral therapy for irritable bowel syndrome induces bidirectional alterations in the brain-gut-microbiome axis associated with gastrointestinal symptom improvement. Microbiome 2021;9:236. [Crossref] [PubMed]
43. Lackner JM, Jaccard J, Keefer L, et al. Improvement in Gastrointestinal Symptoms After Cognitive Behavior Therapy for Refractory Irritable Bowel Syndrome. Gastroenterology 2018;155:47-57. [Crossref] [PubMed]
44. Owusu JT, Sibelli A, Moss-Morris R, et al. A pilot feasibility study of an unguided, internet-delivered cognitive behavioral therapy program for irritable bowel syndrome. Neurogastroenterol Motil 2021;33:e14108. [Crossref] [PubMed]
45. Tonkin-Crine S, Bishop FL, Ellis M, et al. Exploring patients' views of a cognitive behavioral therapy-based website for the self-management of irritable bowel syndrome symptoms. J Med Internet Res 2013;15:e190. [Crossref] [PubMed]
46. ClinicalTrials.gov. The efficacy and safety of IBS digital behavioral treatment study. metaMe Health 2022-04-06. Available online: https://clinicaltrials.gov/ct2/show/NCT04133519
47. Campbell AN, Nunes EV, Matthews AG, et al. Internet-delivered treatment for substance abuse: a multisite randomized controlled trial. Am J Psychiatry 2014;171:683-90. [Crossref] [PubMed]
48. Chaple M, Sacks S, McKendrick K, et al. A comparative study of the therapeutic education system for incarcerated substance-abusing offenders. The Prison Journal 2016;96:485-508.
49. Luderer HF, Campbell ANC, Nunes EV, et al. Engagement patterns with a digital therapeutic for substance use disorders: Correlations with abstinence outcomes. J Subst Abuse Treat 2022;132:108585. [Crossref] [PubMed]
50. Xiong X, Braun S, Stitzer M, et al. Evaluation of real-world outcomes associated with use of a prescription digital therapeutic to treat substance use disorders. Am J Addict 2023;32:24-31. [Crossref] [PubMed]
51. Bickel WK, Marsch LA, Buchhalter AR, et al. Computerized behavior therapy for opioid-dependent outpatients: a randomized controlled trial. Exp Clin Psychopharmacol 2008;16:132-43. [Crossref] [PubMed]
52. Christensen DR, Landes RD, Jackson L, et al. Adding an Internet-delivered treatment to an efficacious treatment package for opioid dependence. J Consult Clin Psychol 2014;82:964-72. [Crossref] [PubMed]
53. Marsch LA, Guarino H, Acosta M, et al. Web-based behavioral treatment for substance use disorders as a partial replacement of standard methadone maintenance treatment. J Subst Abuse Treat 2014;46:43-51. [Crossref] [PubMed]
54. Feuerstein S, Hodges SE, Keenaghan B, et al. Computerized Cognitive Behavioral Therapy for Insomnia in a Community Health Setting. J Clin Sleep Med 2017;13:267-74. [Crossref] [PubMed]
55. Thorndike FP, Saylor DK, Bailey ET, et al. Development and Perceived Utility and Impact of an Internet Intervention for Insomnia. E J Appl Psychol 2008;4:32-42. [Crossref] [PubMed]
56. Moss-Morris R, McAlpine L, Didsbury LP, et al. A randomized controlled trial of a cognitive behavioural therapy-based self-management intervention for irritable bowel syndrome in primary care. Psychol Med 2010;40:85-94. [Crossref] [PubMed]
57. Palsson OS, Turner MJ, Johnson DA, et al. Hypnosis treatment for severe irritable bowel syndrome: investigation of mechanism and effects on symptoms. Dig Dis Sci 2002;47:2605-14. [Crossref] [PubMed]
58. Hunt GM, Azrin NH. A community-reinforcement approach to alcoholism. Behav Res Ther 1973;11:91-104. [Crossref] [PubMed]