FDA Releases Final Premarket Guidance for Medical Device Manufacturers on Secure Data Exchange

The U.S. Food and Drug Administration (FDA) has released final guidance on medical device interoperability, making several recommendations for smart, safe, and secure interactions between medical devices and health IT systems.

The FDA says, “Advancing the ability of medical devices to exchange and use information safely and effectively with other medical devices, as well as other technology, offers the potential to increase efficiency in patient care.”

Providers and patients are increasingly reliant on rapid and secure interactions between medical devices. All medical devices must therefore be able to reliably communicate information about patients to healthcare providers and work seamlessly together. For that to be the case, safe connectivity must be a central part of the design process. Manufacturers must also consider the users of the devices and clearly explain the functionality, interfaces, and correct usage of the devices.

The guidelines spell out what is required and should help manufacturers develop devices that can communicate efficiently, effectively, and securely; however, the guidelines are only recommendations and are not legally enforceable. It is down to each manufacturer to ensure the recommendations are incorporated into the design of the devices.

FDA Associate Director for Digital Health, Bakul Patel, Patel explained in a recent blog post that the guidelines focus on three key areas: Ensuring interoperability is at the core of the design of their devices, that verification, validation and risk management activities are performed, and that the functional, performance, and interface characteristics of the devices are clearly specified to ensure users.

In terms of interoperability, the guidelines say, “In designing a medical device’s electronic interface, manufacturers should consider the level of interoperability needed to achieve the purpose of the interface, as well as the information necessary to describe the interface.”

Manufacturers should “address the risks associated with the anticipated users of the device, reasonably foreseeable misuse of the device, and reasonably foreseeable combinations of events that could result in a hazardous situation.”

Devices must also be clearly labelled to advise users of the functional, performance and interface characteristics, including explicit warnings against foreseeable uses that could result in harm.

Patel explained, the FDA’s main concern is safety. “Errors and inadequate interoperability, such as differences in units of measure (e.g., pounds vs. kilograms) can occur in devices connected to a data exchange system. Our guidance recommends appropriate functional, performance, and interface requirements for devices with such interactions.”

Manufacturers should be transparent about the functions and characteristics of the devices and their interfaces to ensure those using the devices with systems and devices can do so safely. If it is not clearly explained to users how the devices function and interface, this could potentially lead to devices malfunctioning, which would have an impact on patient safety. The guidelines say, “The manufacturer should determine the appropriate way to provide the information based upon the anticipated users and the risk analysis.”

Patel explained, “Our guidance is a good step towards safer devices, and we will continue to work with all stakeholders to adapt along with the technology.”

The final guidelines can be downloaded here.

Author: Steve Alder has many years of experience as a journalist, and comes from a background in market research. He is a specialist on legal and regulatory affairs, and has several years of experience writing about HIPAA. Steve holds a B.Sc. from the University of Liverpool.