The Department of Health and Human Services (HHS) will issue a notice of proposed rulemaking (NPRM) in May to modify HIPAA privacy and security rules as necessary to enforce provisions of the HITECH Act, according to a semi-annual regulatory agenda in the April 26 Federal Register.
No further details were disclosed on what modifications might be made. Although dates are not binding, the agenda stated that it presents “a forecast of the rulemaking activities that HHS expects to undertake in the foreseeable future.”
Also on the agenda is an NPRM release from the FDA, slated for October, to amend the regulations governing the format in which clinical study data and bioequivalence data are required to be submitted for new drug applications, biological license applications and abbreviated new drug applications.
In addition, a NPRM is set to be issued in December by the FDA concerning the regulations to establish a unique identification system for medical devices requiring the label of medical devices to bear a unique identifier, unless the agency specifies an alternative placement or provides for exceptions. “The unique identifier must adequately identify the device through distribution and use, and may include information on the lot or serial number,” the agenda states.
To see the full agenda, click here.