OCR Issues Proposed Modifications to HIPAA Privacy and Security Rules

Guest commentary from Daniel F. Gottlieb, Bernadette M. Broccolo, Jennifer S. Geetter, Jerry Tichner, Jeanna Palmer Gunville, Sarah S. Nelson, Edward G. Zacharias and Stephen W. Bernstein, attorneys in the Health Industry Advisory Practice Group of global law firm McDermott, Will & Emery, LLP

[Editor’s note: Due to its length, this guest commentary will be presented in a series of three blog posts on consecutive days. Part 1 appears below.]


New categories of business associates
As required by the HITECH Act, the Proposed Rule would amend the definition of “business associate” to specify that the following additional categories of entities are business associates and, therefore, directly subject to the Administrative Simplification Regulations: organizations that provide data transmission services and that require routine access to such PHI, including health information organizations, regional health information organizations and e-prescribing gateways; and vendors that offer a personal health record to patients on behalf of a covered entity.

Application of certain HIPAA requirements to business associates
The current Security Rule and Privacy Rule impose requirements on covered entities, which include certain health care providers, health plans and health care clearinghouses, and do not regulate business associates directly. Instead, the rules require covered entities to enter into business associate agreements that contractually obligate their business associates to comply with certain business associate agreement requirements. One of the most significant changes made by the HITECH Act was the extension of certain HIPAA and Administrative Simplification Regulation requirements to business associates.

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