45 CFR 160 - GENERAL ADMINISTRATIVE REQUIREMENTS

The Office of the Secretary of the Department of Health and Human Services (HHS) in coordination with the Office of Science and Technology Policy (OSTP) is extending the comment period for an advance notice of proposed rulemaking (ANPRM) requesting comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective. That ANPRM was published in the Federal Register on July 26, 2011.

The Office of the Secretary of the Department of Health and Human Services (HHS) in coordination with the Office of Science and Technology Policy (OSTP) is issuing this advance notice of proposed rulemaking (ANPRM) to request comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective. This ANPRM seeks comment on how to better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. The current regulations governing human subjects research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site. Although the regulations have been amended over the years, they have not kept pace with the evolving human research enterprise, the proliferation of multi-site clinical trials and observational studies, the expansion of health services research, research in the social and behavioral sciences, and research involving databases, the Internet, and biological specimen repositories, and the use of advanced technologies, such as genomics. Revisions to the current human subjects regulations are being considered because OSTP and HHS believe these changes would strengthen protections for research subjects.

Section 1104 of the Administrative Simplification provisions of the Patient Protection and Affordable Care Act (hereafter referred to as the Affordable Care Act) establishes new requirements for administrative transactions that will improve the utility of the existing HIPAA transactions and reduce administrative costs. Specifically, in section 1104(b)(2) of the Affordable Care Act, Congress required the adoption of operating rules for the health care industry and directed the Secretary of Health and Human Services to “adopt a single set of operating rules for each transaction * * * with the goal of creating as much uniformity in the implementation of the electronic standards as possible.” This interim final rule with comment period adopts operating rules for two Health Insurance Portability and Accountability Act of 1996 (HIPAA) transactions: eligibility for a health plan and health care claim status. This rule also defines the term “operating rules” and explains the role of operating rules in relation to the adopted transaction standards. In general, transaction standards adopted under HIPAA enable electronic data interchange through a common interchange structure, thus minimizing the industry's reliance on multiple formats. Operating rules, in turn, attempt to define the rights and responsibilities of all parties, security requirements, transmission formats, response times, liabilities, exception processing, error resolution and more, in order to facilitate successful interoperability between data systems of different entities.