The American Medical Informatics Association is asking Congress to amend a central federal healthcare privacy rule to give medical researchers access to patient records without their consent.
A see-saw battle has been waged at the federal policy level for more than a decade over patient consent regarding medical records, with patient privacy advocates arguing that control over information about one's self is the definition of privacy.
So, not surprisingly, a leading privacy advocate reacted negatively to the AMIA request.
“It's shocking that they don't have enough data yet, they're going after more?” said Dr. Deborah Peel, a psychiatrist who heads the Patient Privacy Rights Foundation in Austin, Texas. “We completely support the opinion that every research use should be disclosed to the patient.”
The recommendation from 4,000-member AMIA was delivered in a five-page letter to Rep. Fred Upton (R-Mich.) (PDF), chairman of the House Energy and Commerce Committee.
The letter comes in response to Upton's 21st Century Cures initiative which he launched in May with Rep. Diana DeGette (D-Colo.). The initiative seeks to “help accelerate the discovery, development and delivery of promising new treatments to patients” in part by promoting the secondary use of patient data in biomedical research.
AMIA is calling on Congress to amend the Health Insurance Portability and Accountability Act of 1996, a key federal healthcare privacy law. A 2002 revision of the HIPAA rule removed a requirement that providers, health plans and other HIPAA “covered entities” first obtain a patient's consent before sharing medical records for “treatment, payment and other healthcare operations,” commonly known as TPO.
AMIA wants to add research to that list of exempted purposes, thereby removing the consent requirement to use patient information for research.
The letter was signed by Dr. Blackford Middleton, AMIA's board chairman and Dr. Ross Martin, its vice president for policy and development.
AMIA's new President and CEO Dr. Doug Fridsma said the issues the letter addresses are “long-standing.”
The 2009 American Recovery and Reinvestment Act mandated that Congress require providers to give patients, on request, an accounting of the disclosures of their medical records, even for TPO. Some five years later, HHS has failed to write a rule covering that part of the law.
Follow Joseph Conn on Twitter: @MHJConn