Three Agencies Expect to Issue New Regs, Revise Security, Privacy Rules

Two HHS offices with oversight of federally funded research plan to issue three proposed and/or final rules this year affecting research misconduct and human subject protections. And medical schools and other institutions that provide health care as well as conduct research may see changes this year in the HIPAA Privacy and Security rules, enforced by the Office for Civil Rights (OCR). Then again, perhaps they won’t.

The process of creating laws is often described as sausage-making—hidden, messy, something you maybe don’t really want to see until it’s done. There’s a corollary to issuing regulations. The federal process of rulemaking is most visible in the Federal Register upon publication of requests for information, proposed, interim final and then final rules.

But before that happens, the drafting and finalization process plays out among agency staff with periodic mentions in the public but lesser-known Unified Agenda of Regulatory and Deregulatory Actions. Posted twice yearly—in spring and fall—the most recent version was published Dec. 6.

Because the regulated community can have the most impact during the drafting process, it’s useful to keep abreast of what the rulemaking agencies are up to. When reviewing the Unified Agenda, however, it’s important to note that the dates agencies list for issuing a regulation are estimates and are often missed, with subsequent updates containing later dates for publication—sometimes much later. In other instances, the agenda is outdated before it is even posted, and rules it reports as in process have already been issued.

With that as background, the following is regulatory news of note to research compliance officials organized by the agency involved.

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