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FDA Guidance on Medical Device Interoperability is Coming


Posted in Regulatory and Compliance by Jamie Hartford on February 21, 2014

The guidance is part of CDRH’s broader effort to evaluate and better understand efforts that would make medical devices and health information technology systems better connect and share data. 


By Jim Dickinson

                  

FDA says it plans to release this year a draft guidance on medical device interoperability. Speaking at an Office of the National Coordinator for Health Information Technology conference on medical interoperability in February, CDRH director Jeffrey Shuren said the guidance is part of the center’s broader effort to evaluate and better understand efforts that would make medical devices and health information technology systems better connect and share data, according to a report by ModernHealthcare.com.

Recently, the agency identified 25 voluntary standards that can be used by manufacturers as they develop interoperable devices, Shuren said. CDRH also plans to review additional standards this year, he added.

Last year at the International Conference on Medical Device Standards and Regulation, CDRH Division of Electrical and Software Engineering director Al Taylor observed that the term “interoperability” can have at least two meanings with respect to medical devices. In the domain of electronic health record systems, interoperability means the ability to seamlessly share patient information among healthcare providers and payers. At the patient bedside, interoperability means the ability of medical devices to share information and autonomously coordinate aspects of patient care, with the purpose of helping to alleviate the caregivers’ workload.

There are many practical reasons for device interoperability, or the ability of devices to share information, Taylor said. Among them, he pointed to the ability to generate billing information for medical services rendered; to generate a record of “what happened” for legal purposes, or to support quality improvement; or to display real-time information on a patient’s condition, both in the operating room and at a remote location.

Taylor stressed that there is always some risk in transmitting information from one device to another, particularly as information security may be compromised. For this reason, he said, it is often necessary for systems engineers to make the interaction between devices more complex in order to “vet” the ultimate recipient of the information and to verify that he or she has a “need to know.”

It remains to be seen what priority CDRH will place on getting the interoperability guidance out. According to the center’s recent guidance agenda, device interoperability was placed on its “B” list, meaning it will be published as resources permit.

Jim Dickinson is MD+DI's contributing editor. 

[image courtesy of RENJITH KRISHNAN/FREEDIGITALPHOTOS.NET]


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