These are two more of the non-fulfillment exceptions to the ONC rule. Another three fulfillment exceptions follow. The exceptions try to balance the ability of the developers and practitioners to provide technical and medical solutions with the patient’s desire for privacy and security of his/her medical records.
The Office of the National Coordinator for Health Information Technology (ONC), which is part of the Department of Health and Human Services, approved a final rule which implements certain provisions of the 21st Century Cares Act.
Why Medical Device Companies Need to Fear FDA Warning Letters
The FDA examines whether medical devices comply with the regulations of the Food, Drug, and Cosmetic Act. Two of the most common violations medical device companies are charged are adulteration of the products and misbranding.