The FDA is focusing on safety and effectiveness of interconnected medical devices with the issuance of final guidance on medical device interoperability, released last week. As the FDA notes, medical devices are becoming increasingly connected to one another and to other technologies, and it is critical to address their ability to exchange and use information safely and effectively.

For device manufacturers, this guidance provides clarity on how the FDA is thinking about interoperability and patient safety in the premarket submission process and provides considerations for manufacturers in the development and design of interoperability medical devices. It demonstrates the FDA’s focus on the safety and effectiveness of devices as implemented in an interconnected environment and the expectations of FDA on manufactures to anticipate and design for anticipated uses and reasonably foreseeable misuses. Manufactures should consider this guidance in the design, development, and on-going monitoring of connected medical devices.

This guidance may be helpful for other audiences as well:

  • Care providers that frequently interact with medical devices in the course of patient care
  • Hospital IT teams who make device purchasing decisions
  • Vendors of health technologies that frequently exchange data with medical devices

Continue Reading Interoperability by Design: FDA Issues New Final Guidance for Connected Medical Devices

Crowell & Moring and Accenture co-hosted a conference, “Fostering Innovative Digital Health Strategies,” in late-June. The program aimed to provide a broad analysis of the business and legal issues that must be addressed as health care organizations and technology companies consider innovative strategies to use digital health technologies.

The first session of the conference, “Trends in the Health Care Economy’s Internet of Things,” featured the following distinguished panelists: Zane Burke (president, Cerner); Jodi Daniel (partner, Crowell & Moring); Cheryl Falvey (partner, Crowell & Moring); Melissa Goldstein (assistant director, Bioethics and Privacy Office of Science and Technology Policy, Executive Office of the President); and Kaveh Safavi (senior managing director, Global Health Industry Lead, Accenture).

A series of five videos from the session can be watched below:

Here are key health care Internet of Things (IoT) trends discussed in Session 1:

Continue Reading 6 Trends in the Health Care Economy’s Internet of Things