The most eagerly awaited — if not anxiety-laden — set of regulations in the healthcare spectrum arrived late Thursday: HHS issued modifications to the HIPAA Privacy, Security, Enforcement and Breach Notification Rules. The man charged with enforcing the rules said they represent "sweeping changes."

“This final omnibus rule marks the most sweeping changes to the HIPAA Privacy and Security Rules since they were first implemented," Leon Rodriguez, director of the HHS Office for Civil Rights, said in a prepared statement.The changes, he said, "not only greatly enhance a patient’s privacy rights and protections, but also strengthen the ability of my office to vigorously enforce the HIPAA privacy and security protections, regardless of whether the information is being held by a health plan, a healthcare provider or one of their business associates.”

Speaking at the Healthcare IT News/HIMSS Media Privacy & Security Forum in December, Rodriguez noted that until three or so years ago, the agency’s strategy was focused on “specific investigations into specific incidents.” Since HITECH, however, the mandate has been to do something far broader in focus, he said. “We have moved into an area of more assertive enforcement.”

[See also: As OCR promises more fines, two CIOs offer tips on risk assessments.]

He asserted they there would continue to be  “more monetary settlements,” be they from physician practices, hospitals, health plans or state social services agencies.

“Everyone of those is a message to the rest of the industry,” he said.

[See also: Q&A: OCR Director Leon Rodriguez talks audits and enforcements.]

The final rule is composed of four final rules, HHS explains in the document (PDF). They were combined, HHS states, "to reduce the impact and number of times certain compliance activities need to be undertaken by the regulated entities.”

The four parts are:

1. Final modifications to the HIPAA Privacy, Security, and Enforcement Rules mandated by the Health Information Technology for Economic and Clinical Health (HITECH) Act, and certain other modifications to improve the Rules, which were issued as a proposed rule on July 14, 2010. These modifications: