Regulatory and Other Considerations in the Development of Digital Therapeutics 

You are an innovator who sees a healthcare problem that can be addressed, in whole or part, by digital technology (a software-enabled device delivering feedback and improvement in user feel, function, or other metrics).   

One of the earliest determinations you need to make is whether your product will be a consumer-facing or a regulated product, with implications for pathway to market, commercial value, funding, your team, and other strategic matters. 

An illustrative example is a consumer-facing wearable device focused on general wellness that reports on e.g. heartrate or the number of hours you’ve slept in a non-medical setting, that the FDA does not regulate,FN1 in contrast to Continuous Glucose Monitors, or CGMs (even those cleared this year by the FDA for Over-the-Counter, i.e., non-prescription, use), which require at least FDA 510(k) clearance.FN2 

If the intended use and claim for your device is to diagnose or cure, mitigate, treat or prevent a disease, it will be subject to FDA regulation.  While development of an FDA-regulated medical device will require more time, money and clinical data, such a product will typically command a (much) higher price and commercial value. 

Digital therapeutics (or DTx), a category of medical devices that has exploded over the past decade, are software-based medical devices, the use of which are supported by randomized, controlled clinical data to diagnose or cure, mitigate, treat or prevent a disease or condition in a particular patient population.FN3   

Over three dozen DTx products have been approved or cleared by the FDA, for indications in mental health (such as depression, anxiety, schizophrenia, ADHD and insomnia), cardiometabolic diseases (such as diabetes monitoring and treatment), and treatment, prevention of chronic conditions (such as pain), among others.FN4   

FDA’s Center for Devices and Radiological Health (CDRH) regulates DTx as medical devices, technically, as a type of Software-as-a-Medical Device.FN5  Thus, general regulatory considerations, standards and requirements for e.g. Class II 510(k) clearance or Class III De Novo determination, as the case may be, apply.  However, FDA has recognized that software, particularly when combined with Machine Learning/AI that iteratively improves with incremental use via mechanisms such as predetermined change control plans (PCCPs), is different from a pharmacological product, where practically every variation constitutes a new product, necessitating a new safety and efficacy assessment.FN6  The FDA has a Digital Health Center of Excellence that spearheads thinking and policy about digital technologies, including DTx.FN7 Informal inquiries regarding the potential regulatory status of such software products are typically submitted to the Digital Health Center of Excellence’s general mailbox at ﷟HYPERLINK “mailto:DigitalHealth@fda.hhs.gov” for initial agency feedback. 

Regulatory issues are not the only challenges for DTx.  Early leaders stumbled on what observers have characterized as reimbursement and business model issues.  However, the potential of DTx appears undeniable, with next generation approaches that are tackling the challenges,FN8 and Medicare proposing to reimburse for mental health DTx.FN9 Despite these current challenges and in light of the proposed next generation approaches, manufacturers continue to seek clearance for digital therapeutics, especially in the mental health space, where there is a significant need for more at home technologies.  For example, the following additional software devices intended to address mental health conditions have recently been cleared in 2024: 

  • MamaLift Plus  – a prescription device intended to treat mild to moderate postpartum depression by improving a patient’s symptoms of depression.FN10 
  • Sleepio – a prescription device intended to treat chronic insomnia as an adjunct to usual care.FN11 
  • Daylight  – a prescription digital therapeutic intended to treat generalized anxiety disorder by improving a patient’s GAD symptoms as an adjunct to usual care.FN12 

It is important to note that the recent clearances cited above were all supported by robust clinical trials that included a control arm. 

Additional uncertainties have arisen with the returning administration of US President-elect Donald Trump, and his nominees such as Robert F. Kennedy, Jr. to head the Department of Health and Human Services (with oversight over the FDA, the National Institutes of Health, the Centers for Disease Control and the Centers for Medicare and Medicaid Services) and Marty Makary to head FDA, and the recent appointment of Michelle Tarvin as the new CDRH director, after Jeff Shuren’s 15-year tenure.  Crosscurrents such as deregulation and reduction of the administrative state, on the one hand, and greater transparency and safety of regulated products, on the other, portend a period of heightened risks and opportunities for developers of DTx and other rapidly innovating life science products. 

____________  

FN1  See, e.g.:  chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.fda.gov/media/90652/download  

FN2  See, e.g.:  https://www.youtube.com/watch?v=IAJQqQ3oVpE&t=157s

FN3 See, e.g.:   https://htdhealth.com/insights/digital-therapeutics-explained/#:~:text=What%20is%20unique%20about%20digital,remove%20the%20health%20provider%20entirely.  

FN4  https://www.nature.com/articles/s41746-023-00777-z#Tab3 

FN5  https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd 

FN6  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial.   

FN7  https://www.fda.gov/medical-devices/digital-health-center-excellence/guidances-digital-health-content 

FN8  See e.g.:  https://pharmaphorum.com/digital/fall-and-rise-digital-therapeutics 

FN9  https://www.statnews.com/2024/07/25/health-tech-news-medicare-dtx-codes-hhs-revamp-fda/  

FN10 K223515.pdf 

FN11 K233577.pdf 

FN12 K233872.pdf 

About the authors

Thomas Seoh
CEO of Kinexum

Thomas Seoh is CEO of Kinexum, a regulatory, clinical, product and corporate development advisory firm, representing clients before FDA, MHRA and EMA, performing sell- and buy-side due diligence for banks, funds and companies, and advising emerging companies on development strategy and planning, and EVP of the not-for-profit Kitalys Institute, promoting the preemption of chronic diseases and extension of healthy longevity.  He previously held senior management and board roles in emerging biotech, pharmaceutical and medtech companies and startups, after practicing corporate law in New York City and London. 

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Kelliann Payne
Partner in the Global Regulatory practice of Hogan Lovells

Kelliann Payne is a Partner in the Global Regulatory practice of Hogan Lovells, specializing in medical devices, including digital health and diagnostic products and machine learning-based clinical decision support software.  She has extensive experience with premarket submissions and medical device regulatory development strategy, as well as advertising and litigation.  Previously, she was Assistant General Counsel at QVC, Inc., counseling on FDA and FTC regulation on health, wellness, beauty and cosmetic products. 

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