Companies developing digital therapeutics, clinical decision support apps, and other digital health technologies for use in the coronavirus (COVID-19) pandemic should be mindful of FDA’s quickly evolving policies and guidance affecting such technologies. In our recent LawFlash, FDA Regulation of COVID-19 Apps, Digital Therapeutics, and other Digital Health Technologies, we examine recent FDA developments and their implications for companies in the digital health space.
For example, FDA has issued several new guidance documents describing policies of enforcement discretion to help promote the development and availability of digital health technologies for COVID-19. FDA also has issued multiple Emergency Use Authorizations for new COVID-19-related digital health products, and has issued guidance intended to clarify when clinical decision support software is subject to FDA oversight. It is critical for companies seeking to develop digital health technologies for pandemic-related uses to determine whether and how their products may be regulated by FDA.
Additionally, the evolving landscape of medical technology and the accompanying confidential or sensitive data those technologies work with make companies particularly vulnerable to targeted cyberattacks. In a prior Tech & Sourcing Blog Post, it was noted that the recent surge in internet-connected devices presents several challenges to the world of cybersecurity, and in another some of the practical considerations in managing and designing these sorts of devices was further explored. It is critical that user agreements and privacy policies are adapted with the proper legal provisions and protections in place in the event of a breach. As mentioned above, after determining whether certain FDA requirements are applicable, it is equally paramount that companies assess and reassess their continued compliance.