HR 3962 – Health Care Reform
Signed into law on June 25, 2010
SEC. 2571. NATIONAL MEDICAL DEVICE REGISTRY
(b) Electronic Exchange and Use in Certified Electronic Health Records of Unique Device Identifiers-
(2) STANDARDS, IMPLEMENTATION CRITERIA, AND CERTIFICATION CRITERIA-
Secretary of Health and Human Services, acting through the head of the Office of the National Coordinator for Health Information Technology, shall adopt standards, implementation specifications, and certification criteria for the electronic exchange and use in certified electronic health records of a unique device identifier for each covered device referred to in paragraph (1), if such an identifier is required by section 519(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(f)) for the device.
(c) Unique Device Identification System-
The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue proposed regulations to implement section 519(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(f)) not later than 6 months after the date of the enactment of this Act.
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