Amid a global pandemic, digital health has emerged more robust than ever. According to Rock Health, funding is closing in on twelve billion dollars. The rapid shift to virtual care by health systems in the USA has also increased interest in leveraging digital tools to support care delivery.
Despite all this growth, challenges remain for digital therapeutics if they are to enjoy broad adoption. A new perspective by Nisarg Patel and colleagues from UCSF in California published in Nature Digital Medicine examines the road ahead for digital therapeutics.
Digital therapeutics, by design, can diagnose, monitor, and treat chronic conditions as stand-alone support or as a way to augment current models of care. They are usually software-driven interventions and can also have a hardware component like a glucometer or blood pressure monitor. Like drugs, these therapeutics go through FDA clearance and can be accessed directly or via a prescription from your doctor.
The authors reflect on the FDA pathway to approval; while regulatory paths have been built to approve Software as a Medical Device (SaMD), nine products are part of a pilot pipeline to determine digital tools’ product lifecycle. One challenge is the fast pace of digital tools’ evolution. Many now have machine learning elements embedded into the design, so regulatory paths need to be stringent enough to map to standards and flexible enough to allow innovative ways to optimize new ways to support chronic condition management. Continued development of real-world evidence generation will be essential to inform regulatory guidance.
This year has also seen a significant rise in hacking events, especially in healthcare. Addressing security and governance in digital therapeutics is another area the authors discuss. Currently, a two-tier system exists to frame threats to cybersecurity. Tier one considered high risk by the FDA relates to solutions that also have connected devices, like sensors and wearables. The concern here is a breach that could lead to patient harm. Tier two devices are considered a standard security risk. The authors point out that while the FDA has issued guidance on design elements and security considerations in premarket submission, it has yet to mandate premarket security audits. For over a decade, only 2% of these products met the standard laid out by the FDA, a critical vulnerability that will hamper broader adoption in the future.
Data use, transparency, and data rights are also gaining prominence. As consumers, are you aware of how your data is used in apps you currently use regularly. This is an area that requires further development and clarity. The 21st Century Cures Act allows patients more access to their healthcare data. Now, the FDA guidance focuses on the product’s intended use and doesn’t necessarily address all the products’ capabilities. Some movement to close this gap is warranted.
Reimbursement remains complex for digital therapeutics. Even though these tools have been available for five years or more, Centers for Medicaid and Medicaid Services (CMS) have yet to move toward digital therapeutics coverage, despite intense lobbying from the industry. CMS coverage is often the first step in the movement toward broader coverage by the health care industry. The authors note that in late 2019 two of the largest pharmacy benefit management companies, namely CVS and ExpressScripts, developed digital health formularies. The standard codes the FDA issues to drugs, known as the FDA National Drug Code (NDC) and National Health Related Items Code (NHRIC) numbers for medical device reimbursement within pharmacies have not been issued as standard for digital therapeutics. Some products did historically receive that number. This practice will not be allowed after September 2021. Instead, digital therapeutics will be awarded a unique device identification (UDI) number from the FDA, which may hamper their adoption and path to reimbursement.
There is little doubt the digital health industry is strong and likely to grow in prominence in the next three years. While challenges remain, significant inroads in adoption and implementation have been made. It is also clear that digital elements in healthcare are broadening and deepening to address healthcare delivery’s business and clinical aspects. It will be essential to add value to clinicians’ workflows by having access to digital therapeutics without adding additional burden to their schedules while offering engaging and clinically meaningful support to patients.
Thanks for reading – Trina
(Opinions are my own)
Rock Health Funding for Digital Health 2020
Patel, N.A., Butte, A.J. Characteristics and challenges of the clinical pipeline of digital therapeutics. npj Digit. Med. 3, 159 (2020). https://doi.org/10.1038/s41746-020-00370-8