FDA Recognizes Medical Devices in Health IT Infrastructure.

“Device design elements that factor in interoperability considerations may improve data portability and patient safety.” The U.S. Food and Drug Administration (FDA) appears intent on positioning medical devices within the realm of health IT infrastructure. Twice this month, the FDA has issued draft guidance on medical devices — first on Jan. 22 relating to cybersecurity, and then on Jan. 26 covering interoperability. The cybersecurity guidance recommends that device manufacturers “implement a structured and systematic comprehensive cybersecurity risk management program and respond in a timely fashion to identified vulnerabilities.”