FDA Playing Tortoise to Digital Health Hare

Regulators are playing catch-up amid the proliferation of digital health-related products, a senior policy adviser for the US Food and Drug Administration said in a BIOMEDevice San Jose talk recounted in EE Times. The FDA's work includes working to define and rationalize guidelines in areas such as security and software. Highlighted issues include making security a part of the design process for medical devices, especially amid cybersecurity concerns."The world of connected health is evolving very quickly," said Bakul Patel of the FDA's Center for Device and Radiological Health. "We believe prevention-based healthcare will lead to better outcomes, and this next healthcare paradigm is emerging right in front of us."

Patel noted that the FDA has initial guidelines in place to help device developers make security a consideration throughout the design process for medical devices. The agency also continues to do research to help establish guidelines to prevent hacking of medical devices. "It's a work in progress," Patel said in the EE Times piece. "We want to get ahead of the problems."

FDA is also working with international agencies to develop common guidelines for regulating medical device sector. For instance, it is working with the International Medical Device Regulators Forum, which has released a 30-page document providing an initial framework for regulating software.

Click here to read the full EE Times story.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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