« Oversight of Synthetic Biology research/products, Federal agencies | Main | Legislative Update »

HHS proposed new rules under HIPAA, privacy website

From HHS news-7/8/10-HHS Secretary Kathleen Sebelius announced important new rules and resources to strengthen the privacy of health information... (1)From the Joint Statement:

[The] proposed regulations under HIPAA of 1996 would expand individuals’ rights to access their information and restrict certain disclosures of protected health information to health plans, extend the applicability of certain of the Privacy and Security Rules’ requirements to the business associates of covered entities, establish new limitations on the use and disclosure of protected health information for marketing and fundraising purposes, and prohibit the sale of protected health information without patient authorization.... strengthen and expand OCR’s ability to enforce HIPAA’s Privacy and Security provisions.(1)
Proposed Modifications highlighting research activities include(2):
- The proposed rule permits compound authorizations for research purposes as long as it is clear to individuals that they do not have to agree to both the conditioned and unconditioned components of an authorization in order to receive research-related treatment. [HHS agrees that allowing a covered provider to combine research authorizations would streamline the process for obtaining an individual’s authorization for research and would make documentation responsibilities of these covered entities more manageable. Such a modification would also result in an authorization that would be simpler and more meaningful to the individual in contrast to the individual receiving multiple forms that may be confusing. ( pp 99-103)
-Research often involves obtaining health info and biological specimens to create a research database or repository for future research, this frequently occurs where clinical trials are paired with corollary research activities. (4)While HHS is not proposing modifications on Authorizing Future Research Use or Disclosure at this time, HHS requests public input. (pp103-106).
The Benefits for individuals under the proposed Rule are described on p167.
Under the Costs of Notifying Individuals of their New Privacy Rights (req'd due to proposed modifications to HITECH), HHS counts over 696, 758 HIPAA covered entities that must prepare /deliver NPPs (NPPs detail how the covered entity may use/disclose protected health info and individual’s rights with respect to their own health info.)—in drafting updated NPPs for approximately 607,000 health care providers in the US, attorney time is figured at $90 per hour, 1/3 of an hour of professional time for each revised NPP. (p152-156)
HHS also launched a privacy website at http://www.hhs.gov/healthprivacy/index.html . See also link to Certificates of Confidentiality,since 1992 issued by NIH to protect identifiable research information from forced disclosure.
(1)http://www.hhs.gov/news/press/2010pres/07/20100708c.html Joint Statement by David Blumenthal, M.D., M.P.P., National Coordinator for Health Information Technology, HHS; Georgina Verdugo, Director, Office for Civil Rights, HHS.
(2) http://www.ofr.gov/OFRUpload/OFRData/2010-16718_PI.pdf Modifications to the HIPAA Privacy , Security and Enforcement Rules under the Health Information Technology for Economic and Clinical Health Act 45 CFR Parts 160 and 164,

-More proposed modifications regarding research activity and drugs/biologics refill prescriptions form a part of longer lists of statutory exceptions regarding authorizations under certain marketing limitations of the HITECH Act, ( p71) and certain limitations in the sale of protected health info. (p94)
From the Proposed Modifications' SUMMARY: HHS is issuing this notice of proposed rulemaking to modify the Privacy Rule, Security Rule and the Enforcement Rule issued under HIPPA of 1996. The purpose of these modifications is to implement recent statutory amendments under the HITECH Act, to strengthen the privacy and security protection of health information and to improve the workability and effectiveness of the HIPAA rules.

Post a comment

(If you haven't left a comment here before, you may need to be approved by the site owner before your comment will appear. Until then, it won't appear on the entry. Thanks for waiting.)

About

This page contains a single entry from the blog posted on July 12, 2010 5:52 PM.

The previous post in this blog was Oversight of Synthetic Biology research/products, Federal agencies .

The next post in this blog is Legislative Update.

Many more can be found on the main index page or by looking through the archives.