The Food and Drug Administration (FDA) recently announced a wide-ranging Digital Health Innovation Plan that will focus on cultivating discovery across the medical field.
With hundreds of thousands of medical apps on the market, consumers and medical professionals are using them to track, diagnose, and manage all sorts of health conditions. And while there are many high quality, evidence-based medical apps out there, we’ve seen over and over again examples of medical apps making false claims that put users at risk, highlighting the need for some form of oversight and curation.
In general, the FDA has kept its focus very narrow in the mobile medical sector, focusing on a small fraction of medical apps and devices using a risk-based approach. More recently, they announced plans for their digital unit.
Now, according to a blog post from the new FDA Director Scott Gottlieb, the FDA is poised to transform how it approaches digital health. First, he notes that the FDA will develop “policies that are clear enough for developers to apply them on their own, without having to seek out, on a case-by-case basis, FDA’s position on every individual technological change or iterative software development.”
Overall, that seems to imply more guidance coming down the road on the types of medical apps and devices the FDA will not be directly scrutinizing, though perhaps offering more specific guidance on best practices in development or quality assurance. In the post, he notes that the 21st Century Cures Act specifically outlines categories of digital health products that fall outside the scope of FDA regulatory authority.
In addition, the FDA will be piloting a new regulatory approach that may involve third-party certification of medical apps and devices. According to Dr. Gottlieb,
…we are considering whether and how, under current authorities, we can create a third-party certification program under which lower-risk digital health products could be marketed without FDA premarket review, and higher-risk products could be marketed with a streamlined FDA premarket review. Certification could be used to assess, for example, whether a company consistently and reliably engages in high-quality software design and testing (validation) and ongoing maintenance of its software products. Employing a unique pre-certification program for software as a medical device (SaMD) could reduce the time and cost of market entry for digital health technologies.
He also mentions the National Evaluation System for Health Technology – a virtual system to collect data from sources including EHRs, registries, insurers, and so on. Operated by a third-party public-private consortium, NEST will offer a more streamlined approach to real-world data collection after a medical app or device has hit the market.
Overall, when it comes to the regulatory landscape in digital health, significant changes seem to be ahead.