Electronic health record developers want health IT that isn’t currently regulated as a medical device to remain that way, pending further review from the FDA, FCC and ONC. The HIMSS Electronic Health Record (EHR) Association, a group that represents more than 40 EHR companies, expressed their opinion in a letter addressed a letter to HHS Secretary Kathleen Sebelius. The letter read that regulation “beyond what is currently in place is not appropriate until further analysis of data and the establishment of a risk-based framework have been completed.” The EHR Association letter was a response to HHS’ cooperation in creating a regulatory framework for medical devices as suggested by the FDA Safety and Innovation Act (FDASIA) Workgroup.
The Health IT Policy Committee approved FDASIA’s draft recommendations for the regulatory framework, which were presented in September at a workgroup meeting. The workgroup’s recommendations will be turned over to the FDA, FCC and ONC. Those three agencies will then develop a final report “on an appropriate, risk-based regulatory framework pertaining to health information technology including mobile medical applications that promotes innovation, protects patient safety, and avoids regulatory duplication.” Additional regulation of health IT beyond current standards is not necessary, according to FDASIA’s report.
The EHR Association’s letter disagrees with an FDASIA idea under consideration that health IT not regulated as medical devices should be labeled “class 0” medical devices by the FDA. The association’s letter states that such a “formal, regulatory approach” to health IT is not warranted. The invention of a “class 0” for medical devices would add a level beneath the least-regulated class I devices. Class I devices include things such as mHealth applications, hospital beds and dialysis chairs.
The FDA recently released its final rule for a unique device identification system for medical devices. The rule requires every medical devices model to have its own unique ID number, for tracking and security purposes. The rule also necessitates the creation of a public database of all medical devices. The rule was established to better organize and identify problems with specific devices.