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Regulations & Guidance
The Health Information Technology for Economic and Clinical Health (HITECH) Act provides HHS with the authority to promulgate regulations and guidance to support the development of an interoperable, private and secure nationwide health information technology infrastructure. 
PCAST Report on Health Information Technology
The President’s Council of Advisors on Science and Technology (PCAST) report, “Realizing the Full Potential of Health Information Technology to Improve Healthcare for Americans: The Path Forward,” [PDF - 1.63 MB] provides recommendations for using health IT to facilitate the real-time exchange of patient information.

The American Recovery and Reinvestment Act of 2009 (Recovery Act) authorizes the Centers for Medicare & Medicaid Services (CMS) to provide reimbursement incentives for eligible professionals and hospitals who are successful in becoming "meaningful users" of certified electronic health record (EHR) technology.

  • CLIA Program and HIPAA Privacy Rule; Patients’ Access to Test Reports [PDF - 163 kb] - The proposed rule would modify the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and the HIPAA Privacy Rule in order to give patients the right to get a copy of their health information, including test results, directly from a clinical lab.

    The HIPAA Privacy Rule gives patients the right to access health information held by most health care providers. However, the Privacy Rule states that there is no patient right of access under HIPAA if access would be prohibited by CLIA. As currently written CLIA often prohibits laboratories from directly releasing test results to patients. Under the proposal, the CLIA regulation will be amended to expressly permit laboratories to release test results directly to patients. The proposed rule would also change the HIPAA Privacy Rule to remove the CLIA exception. Together these changes will give patients the right to access a copy of their test results from their lab in the same manner that they have the right to access health information held by other health care providers. 
  • Modifications to the HIPAA Privacy, Security, and Enforcement Rules under the Health Information Technology for Economic and Clinical Health Act – Notice of Proposed Rulemaking - On July 8, 2010, Secretary Kathleen Sebelius and the Office for Civil Rights (OCR) announced that the 1996 HIPAA Privacy and Security Rules will be modified to add new protections. The proposed new regulations will improve patient privacy and security in health information exchange by extending OCR’s enforcement, giving patients the right to receive their medical information electronically, and setting new limits on the use of protected health information.
     
  • HITECH Breach Notification Interim Final Rule - This document also includes guidance specifying encryption and destruction as the technologies and methodologies that render protected health information unusable, unreadable, or indecipherable to unauthorized individuals.
     
  • Substance Abuse Confidentiality Regulations FAQs - A Frequently Asked Questions (FAQs) document for applying the Substance Abuse Confidentiality Regulations to Health Information Exchanges (HIEs) was released on 6/16/2010. This document is an educational tool that serves as a resource for practitioners in the field, as they are applying the Substance Abuse Confidentiality Regulations to Health Information Exchange activities, but does not provide legal advice to its user.
Electronic Eligibility and Enrollment
Section 1561 of the Affordable Care Act required HHS, in consultation with the Health Information Technology (HIT) Policy Committee and the HIT Standards Committee, to develop interoperable and secure standards and protocols to facilitate electronic enrollment of individuals in Federal and State health and human services programs.
  • Section 1561 Recommendations – The HIT Policy and Standards Committees approved initial recommendations on August 19, 2010 and August 30, 2010 respectively. On September 17, 2010, Secretary Kathleen Sebelius adopted these recommendations with slight edits. These recommendations include initial standards and protocols that encourage adoption of modern electronic systems and processes that allow a consumer to seamlessly obtain and maintain the full range of available health coverage and other human services benefits.
(Drug Enforcement Administration (DEA), U.S. Department of Justice)
DEA’s rule, “Electronic Prescriptions for Controlled Substances” revises DEA’s regulation to provide practitioners with the option of writing prescriptions for controlled substances electronically.  The regulations will also permit pharmacies to receive, dispense, and archive these electronic prescriptions.  DEA’s discussions with the Office of the National Coordinator for Health Information Technology (ONC), Centers for Medicare and Medicaid Services (CMS), and Agency for Healthcare Research and Quality (AHRQ) were instrumental in the development of this rule.  DEA also worked closely with the National Institute of Standards and Technology (NIST) and the General Services Administration (GSA).

To learn more about the federal rulemaking process, to view these documents, and to comment on proposed rules with open comment periods please visit http://www.regulations.gov.

2012/07/18
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