Medical Device Interoperability
What is Medical Device Interoperability?
Medical device interoperability is the ability to safely, securely, and effectively exchange and use information among one or more devices, products, technologies, or systems. This exchanged information can be used in a variety of ways including display, store, interpret, analyze, and automatically act on or control another product.
As electronic medical devices become increasingly connected to each other and to other technologies, the ability of connected systems to safely, securely and effectively exchange and use the information becomes critical.
Interoperable devices with the ability to share information across systems and platforms can:
- Improve patient care,
- Reduce errors and adverse events,
- Encourage innovation, and
- Enable more diverse study datasets.
Cybersecurity concerns rise along with the increasing medical device interoperability. The FDA is aware of cybersecurity issues related to medical devices, and you can learn about the FDA’s activities and recommendations for protecting devices and systems from cybersecurity vulnerabilities at our Cybersecurity page.
How is the FDA involved?
The FDA supports the smart, secure, and safe interaction among different medical devices and information systems. The agency has been collaborating with hospitals, health care providers, manufacturers, standards development organizations, and other interested parties to promote medical device interoperability.
Examples of the FDA's collaboration efforts to advance medical device interoperability include:
- In 2010, the FDA, Continua Health Alliance, and the Center for Integration of Medicine & Innovative Technology (CIMIT) sponsored a public workshop to bring together relevant stakeholders and find common ground for interoperability, safety in an interoperable environment, and regulatory pathways.
- In 2012, the FDA and the Association for the Advancement of Medical Instrumentation (AAMI) identified challenges to device interoperability, including standardization, at a Summit Report Outlines Steps to Address Home Healthcare Technology Challenges. Read more about the summit in the AAMI report, “Medical Device Interoperability: A Safer Path Forward.”
- In 2015, the FDA, the Centers for Disease Control and Prevention (CDC), and the National Library of Medicine (NLM) of the National Institutes of Health (NIH) held a public workshop, “FDA/CDC/NLM Workshop on Promoting Semantic Interoperability of Laboratory Data,” where stakeholders discussed approaches to promoting the semantic interoperability of laboratory data between in vitro diagnostic devices and database systems, including laboratory information systems and electronic health records. A subsequent follow-up workshop was held in 2016 by the CDC, FDA, NIH, the Office of the National Coordinator for Health IT (ONC), and the Centers for Medicare and Medicaid Services (CMS). These workshops resulted in the establishment of the Standardization of Lab Data to Enhance Patient-Centered Outcomes Research and Value-Based Care (SHIELD) public-private partnership aimed at addressing interoperability barriers.
- In 2019, the FDA participated with the National Science Foundation’s Health Information Technology Research and Development Interagency Working Group (HITRD IWG) in the Networking and Information Technology Research and Development (NITRD) National Coordination Office in a Request for Information and Listening Session entitled “The Interoperability of Medical Devices, Data, and Platforms to Enhance Patient Care” in which stakeholders identified priorities for improving interoperability in medical devices.
- For over two years (2020-2022) during the COVID-19 public health emergency, the FDA’s CDRH led the way in diagnostic data interoperability for SARS-CoV-2 in vitro diagnostic tests. Efforts in collaboration with HHS and across the interagency led to significant progress in the standardization, harmonization, and transmission of diagnostic data to inform clinical and public health decisions. A few associated resources and activities are highlighted below:
- Diagnostic Data & Reporting COVID-19 Diagnostic Data Standards: Frequently Asked Questions
- COVID-19 Data Reporting for Non-Laboratory-Based Testing (September 23, 2020) - PDF (Technical Specifications for Implementation)
- COVID-19 TOPx Solutions Showcase #TOPxCOVID
- WATERS (Wireless Automated Transmission for Electronic Reporting Systems), now integrated with CDC ReportStream
In addition to these efforts, the FDA issued the final guidance, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices, in 2017. This guidance helps manufacturers design and develop safe, effective, and interoperable medical devices by outlining important design considerations and providing clarity on the agency’s recommendations for submitting interoperability-related information in premarket submissions and labeling.
Standards are important to the development of reliable interoperable medical devices. Conforming to standards can help in creating medical device systems of interchangeable devices from different manufacturers, leading to new models of health care.
In 2013, the FDA officially recognized an initial set of standards manufacturers could use to improve patient care by making sure devices work well together. The FDA continues to recognize and encourage the use of consensus standards that are relevant to the development and design of interoperable medical devices, including the following:
- ANSI/AAMI 2700-1 (2019) Medical Devices And Medical Systems - Essential Safety Requirements For Equipment Comprising The Patient-Centric Integrated Clinical Environment (formerly ASTM F2761-09 (2013))
- AAMI/ANSI/UL 2800 Series:
- AAMI/ANSI/UL 2800-1 (2022): Standard for Medical Device Interoperability
- ANSI/AAMI/UL 2800-1-1:2022 - Standard for Risk Concerns for Interoperable Medical Products
- ANSI/AAMI/UL 2800-1-2:2022 - Standard for Interoperable Item Development Life Cycle
- ANSI/AAMI/UL 2800-1-3:2022 - Standard for Interoperable Item Integration Life Cycle
- Series of ISO/IEEE 11073 device communication standards for Point of Care Devices and Personal Health Devices
- National Electrical Manufacturers Association (NEMA) PS 3.1 – 3.20 Digital Imaging and Communications in Medicine (DICOM) Set for communication and management of medical imaging information and related data
In many cases, the standards that support interoperability may also be used by other stakeholders such as health care delivery organizations. This may include system integrators, system designers, and information technology professionals who work in health care settings. In other industries, products now have the ability to seamlessly interoperate with each other. For example, in the automotive industry, engine control modules or electronic safety systems may be used on a variety of vehicles, or in electronic products, your smart television can communicate with your Wi-Fi router.
To verify which standards the FDA currently recognizes, please refer to the FDA Recognized Consensus Standards Database.
- The National Institute of Standards and Technology (NIST) website on Medical Device Interoperability This website describes NIST’s efforts to promote standards-based medical device interoperability and communication.
- The Office of the National Coordinator for Health IT’s (ONC) website on Interoperability, including Connecting Health and Care for the Nation: A 10 Year Vision to Achieve an Interoperable Health IT Infrastructure ONC’s vision for a future health IT ecosystem where electronic health information is appropriately and readily available to empower consumers, support clinical decision-making and advance science.
- AAMI White Paper on Medical Device Interoperability An overview of medical device interoperability, including a discussion of what is meant by interoperability, relevant standards, and the challenges in achieving safety.
- The Value of Medical Device Interoperability: Improving Patient Care with more than $30 Billion in Annual Health Care Savings A discussion of the business case for medical device interoperability by West Health Institute.
- Medical Device Plug-and-Play (MD PnP) Interoperability Program A research program investigating patient safety aspects of medical device interoperability and proposed solutions based on open systems.