On February 9, the Department of Health & Human Services (HHS) sent to the Office of Management and Budget (OMB) a proposed rule to implement the requirement in the Health Information Technology for Economic and Clinical Health (HITECH) Act that individuals be given an expanded accounting of disclosures of protected health information (PHI) contained in an electronic health record.  OMB should finish its review within 90 days, and the proposed rule could be published shortly thereafter. 

Under the HIPAA Privacy Rule, upon request from an individual, a covered entity must provide the individual with an accounting of certain disclosures of his/her PHI made by the covered entity during the prior six years.  That accounting need not include disclosures made for purposes of treatment, payment or health care operations.  Under the HITECH Act, if a covered entity maintains an electronic health record, the covered entity must provide the individual, upon request, an accounting that includes disclosures for treatment, payment and health care operations for the prior three years. 

The HITECH Act directs HHS to promulgate regulations implementing the new accounting requirement.  The statute further directs that, “Such regulations shall only require such information to be collected through an electronic health record in a manner that takes into account the interests of the individuals in learning the circumstances under which their protected health information is being disclosed and takes into account the administrative burden of accounting for such disclosures.”  Last May, HHS published a request for information to help inform the agency’s rulemaking in this area.

Prior to the 2003 compliance date for the HIPAA Privacy Rule, many covered entities feared that complying with requests for accountings of disclosure would be one of the more burdensome aspects of Privacy Rule compliance.  Anecdotal evidence, however, indicates that very few individuals have sought to exercise their right to an accounting.  It will be interesting to see how much of an administrative burden on covered entities HHS is proposing in light of the general public’s current lack of interest in obtaining an accounting.

Print:
Email this postTweet this postLike this postShare this post on LinkedIn
Photo of Anna D. Kraus Anna D. Kraus

Anna Durand Kraus advises on issues relating to the complex array of laws governing the health care industry. Her background as Deputy General Counsel to the U.S. Department of Health and Human Services (“HHS”) gives her broad experience with, and valuable insight into…

Anna Durand Kraus advises on issues relating to the complex array of laws governing the health care industry. Her background as Deputy General Counsel to the U.S. Department of Health and Human Services (“HHS”) gives her broad experience with, and valuable insight into, the programs and issues within the purview of HHS, including Medicare, Medicaid, fraud and abuse, and HIPAA privacy and security. Anna is co-chair of the firm’s Health Care Industry practice group.

Anna regularly advises clients on Medicare reimbursement matters, particularly those arising under Part B and the Part D prescription drug benefit. She also has extensive experience with the Medicaid Drug Rebate program. She assists numerous pharmaceutical and device manufacturers, health care providers, pharmacy benefit managers, and other health care industry stakeholders to navigate the challenges and opportunities presented by the Affordable Care Act.

Anna is a trusted adviser on health information privacy, security and breach notification issues, including those arising under the Health Insurance Portability and Accountability Act (“HIPAA”) and the Health Information Technology for Economic and Clinical Health (“HITECH”) Act. Her background in this area dates back to the issuance of the original HIPAA privacy regulations.

Anna’s clients depend on her to guide them through compliance with the Anti-Kickback statute, the Stark regulations, and other laws preventing fraud and abuse in the health care industry. Her deep knowledge of these laws has made her an important component of the firm’s representation of pharmaceutical companies and health care organizations under federal investigation or facing allegations under the False Claims Act. In addition, clients contemplating acquisitions in the health care sector rely on her to guide due diligence efforts.