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Regulatory Focus™ > News Articles > 9 > Gottlieb Defends Digital Health Approach

Gottlieb Defends Digital Health Approach

Posted 27 September 2018 | By Michael Mezher 

Gottlieb Defends Digital Health Approach

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Wednesday defended the agency’s approach to regulating digital health apps following the de novo classification and clearance of two software applications that add atrial fibrillation detection capabilities to the Apple Watch 4.
Unlike with traditional medical devices, where FDA would review the device and its software components, the agency’s approach for medical apps focuses on the software rather than the platform the software runs on.
“FDA’s approach to digital health isn’t to regulate the every-day health and lifestyle uses of consumer devices, but rather to focus our resources on reviewing more sophisticated medical apps that sit on top of this general purpose hardware,” Gottlieb writes.
Gottlieb says this approach allows FDA to get digital health technologies to market more efficiently and will encourage more developers to move into the health space and to fulfill the aims of the agency’s Digital Health Innovation Action Plan.
Indeed, FDA’s decision to classify and clear Apple’s software applications came quickly, roughly a month after Apple submitted its de novo requests and just one day before the company announced the features in its 12 September Keynote.
Gottlieb also stressed that the agency’s efforts in the digital health space will require more funding to keep pace with the rapidly evolving industry. In its FY 2019 budget, FDA requests an additional $70 million to further its digital health efforts.
The new funding will be used to establish a Center of Excellence for Digital Health that Gottlieb says would help advance the agency’s pre-certification model and start work to accredit third-party reviewers for pre-certifying digital health products.
The Center of Excellence would also oversee a new cybersecurity unit and launch a public-private cybersecurity cooperative to complement FDA’s and other governmental agencies’ ongoing cybersecurity efforts.
“Cybersecurity requires a multi-disciplinary focused team to bring together a range of requisite expertise to fully assess and validate high-risk/high-impact vulnerabilities and incidents, including potential patient safety implications,” Gottlieb writes.


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