Why the FDA will focus on cybersecurity, medtech big data in 2017

Dive Brief:
The FDA’s Center for Devices and Radiological Health (CDRH) laid out its 2017 regulatory science priorities, targeting ten areas including cybersecurity and medical device big data.
Also among the priorities are several new focus areas, such a precision medicine and clinical trial design.
The report serves as a roadmap for enhancing the safety, effectiveness and quality of medical devices, and radiation-emitting devices that the center regulates.
Dive Insight:
With so many patients attached to medical devices, and increasing use of digital health apps, it’s important to ensure they perform as desired and are safe from cyber attacks.

In July 2015, the FDA issued an alert about the vulnerability of Hospira’s Symbiq drug infusion pump to hackers via a hospital’s wireless network. The agency also released draft guidance earlier this year that looked at both premarket and postmarket cybersecurity concerns with devices.

To address these concerns, CDRH plans studies to identify categories of software modifications that could negatively impact device safety and effectiveness and research on adapting the standard rating system for IT vulnerabilities to include issues unique to the healthcare environment.

“By enhancing the performance of digital health and strengthening device cybersecurity, we will improve the safety and reliability of interconnected medical devices,” the report says.

CDRH wants to develop nonclinical methods for assessing the long-term monitoring capabilities and predictive capacity of smart implants. And it seeks better computational and statistical tools to speed device evaluation.


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