In an era marked by collaborative care and electronic health records, healthcare informatics tools are increasingly in demand. But bringing new imaging informatics solutions to market is no easy feat. Vendors must contend with an array of challenges from development to testing to regulatory compliance.
In a new report, three Federal Agencies agreed on the scope of their regulatory domain and determined that the FDA will continue to be the regulator for medical imaging informatics.
The Medical Imaging & Technology Alliance (MITA) applauded the U.S. Food and Drug Administration (FDA), Office of the National Coordinator (ONC) for Health Information Technology (HIT) and the Federal Communications Commission (FCC) for publishing the “FDASIA Health IT Report Proposed Strategy and Recommendations for a Risk-Based Framework.”
The Report calls for three HIT categories determined by the function and level of risk of each product, ranging from administrative HIT to health management IT to medical device HIT.
“We are pleased that the FDA, ONC and FCC considered MITA’s guidance in the development of a proposed strategy that will promote innovation in HIT products, avoid regulatory duplication and protect patients,” said Gail Rodriguez, executive director of MITA. “In a face-paced, technological world, it is critical that regulatory frameworks support the implementation of innovation for patients. MITA looks forward to working closely with the Agencies to finalize and implement these plans.