The U.S. Department of Health and Human Services (HHS) is requesting public input on its plans for facilitating a nationwide system of electronic health records (EHRs) and the use of genetic information in medical care and research, among other issues. Comments must be submitted by February 5, 2007.

In its Federal Register notice HHS stated that many private and government groups are preparing to use the forthcoming electronic medical-records system for collecting and utilizing genetic data. The Federal Register announcement includes the following excerpts [see link below to read the notice in its entirety]:

• “The application of interoperable electronic information technologies (IT) in the health care setting provides new opportunities to collect and analyze information about diagnostic and therapeutic interventions, as well as health care outcomes....”
• “Occurring in parallel with the advances in health IT are advances in molecular and genetic medicine....The ability to integrate new scientific knowledge, especially our growing understanding of the human genome, into the health care setting in an efficient and timely fashion will rely on robust, reliable and secure information sources in electronically interoperable systems. Many public and private organizations are engaged in the planning for future collections and integration of health data for this purpose....”

Citizens wishing to comment should consider the following issues:

• The existing federal medical-privacy rule does not give individuals the final say in who has access to their medical/genetic information. Thus, facilitating EHRs would make it easier to share medical/genetic data without individuals’ consent and therefore diminish Americans’ health privacy.
• Individuals do not have a right to sue under the rule if their privacy is violated. In fact, on November 13, 2006 the U.S. Court of Appeals for the Fifth Circuit, in Acara v. Banks, confirmed that private litigants may not enforce the rule. The only recourse is to file a complaint with HHS.

The bottom line is that the federal government is moving full steam ahead in fostering a national EHR system without ensuring that individuals have the final say in determining who has access to their personal health information—including genetic information. Sigrid Fry-Revere, director of bioethics studies at the Cato Institute, warns, “The U.S. healthcare system is suffering from a serious trust crisis and mandating the collection of medical data may very well add to that crisis....”

Public comments must be submitted to HHS on or before February 5, 2007.

Electronic responses are preferred and should be sent to: PHCRFI@hhs.gov

Written responses should be mailed to:

Attention: Personalized Health Care RFI
Department of Health and Human Services
200 Independence Avenue, S.W., Room 434E
Washington, DC 20201

HHS requests that responders follow these instructions: Any information you submit will be made public. Do not send proprietary, commercial, financial, business confidential, trade secret, or personal information that should not be made public. The submission of written materials in response to the RFI [Request for Information] should not exceed 75 pages, not including appendices and supplemental documents. Responders may submit other forms of electronic materials to demonstrate or exhibit key concepts of their written responses. For further information, contact: Dr. Gregory Downing, Personalized Health Care Initiative, (202) 260–1911.

Sources:

• “Request for Information (RFI): Improving Health and Accelerating Personalized Health Care Through Health Information Technology and Genomic Information in Population and Community-Based Health Care Delivery Systems,” Federal Register (Vol. 71, No. 211), November 1, 2006, pp. 64282-4: http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/E6-18371.pdf and Federal Register (Vol. 71, No. 239), December 13, 2006, p. 74914 (re: extension of comment period): http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/E6-21146.pdf
• “HHS Considering Nationwide System of Electronic Healthcare Records,” by Sigrid Fry-Revere, Cato Institute, December 15, 2006: http://www.cato-at-liberty.org/index.php?cat=13&submit=GO
• “About Health Care (HIPAA Privacy Rules),” Mcglinchey Stafford PLLC, December 5, 2006: http://www.mcglinchey.com/publications/newslettermonth.asp?article=1008&issue=12&vol=2006