CHIME says FDA device interoperability guidance not strict enough

Draft guidance from the FDA on making sure medical devices and electronic records are interoperable doesn't go far enough, according to a letter to the FDA from the College of Healthcare Information Management Executives (CHIME).

First proposed in January, the guidance seeks “to promote the development and availability of safe and effective interoperable medical devices.” While CHIME supports this goal, the letter makes the argument for setting stricter “baseline uniform standards” required for FDA approval of devices, rather than the non-binding suggestions of a guidance.

Among CHIME’s specific recommendations:

• Collaborate with the Office of the National Coordinator (ONC), providers, device manufacturers, other appropriate stakeholders to establish a baseline set of uniform interoperability standards for devices that must be met in order to receive FDA approval;
• Work with ONC and interested stakeholders to establish a more robust definition of interoperability;
• Work with ONC to have them certify APIs;
• Synchronize efforts across with other federal agencies in applying risk management principles;
• Require that device manufacturers to perform a risk assessment annually on their devices;
• Ensure alignment between the FDA’s cybersecurity guidance for device manufacturers and the interoperability guidance;
• Require device functionality receive the same level of transparency as EHRs;
• Create a central, online database that includes key functionality of devices (i.e., interoperability and security).

You can read the full letter by clicking the link below: