Will Congress Expand Intrusion by Calling it "Research"?

May 20, 2015

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Titles of legislation often deceive. Consider H.R. 6, the “21st Century Cures Act” authored by Rep. Fred Upton (R-MI). The U.S. House Energy and Commerce Committee meets tomorrow to advance this bipartisan bill, which will: 1) hand over your private health data to millions of corporate and government outsiders for so-called “research”; and 2) prohibit electronic health records (EHR) from interfering with such research.
Your consent would not be required. As the bill says in the interoperability section: “health care providers do not need the consent of their patients to share personal health information of such patients with other covered entities, in compliance with the HIPAA privacy regulations…” (Subtitle A, Title III)
Bills with the best titles are often the worst. President Obama’s “Patient Protection and Affordable Care Act” imposes unaffordable national managed care on all Americans. The “Health Insurance Portability and Accountability Act” (HIPAA) eliminated most medical privacy rights.
The “Cures Act” would permit major new intrusions into private lives.  As the American Hospital Association told Politico Pro, the bill “is too broadly encompassing in allowing access to patient data for undefined research purposes; this undermines the trusted relationship between providers and their patients.” Specifically, section 1124 reclassifies research in the following subsections:
  • Defining Health Data Research as Part of Health Care Operations
  • Treating Disclosures of Protected Health Information for Research Similarly to Disclosures of Such Information for Public Health Purposes.
The details of your medical records will be available for any “research” related to public health (PH) or health care operations (HCO), including profiling, tracking, and analysis of patients and doctors. The federal definition of HCO is an astonishing 390 words long! And “public health” can be whatever the government says it is. HCO and PH could include experimentation at the bedside…without your consent. This is sometimes called Continuous Quality Improvement (CQI or QI). As the Hastings Center reports:
Federal agencies with responsibilities in this area have disagreed on where the interface between medical research and QI lies and how it should be handled. … The current state of uncertainty about what is ethically and legally required to safeguard participants in QI activities has already become a disincentive to engage in QI...
By reclassifying health data research, the “Cures Act” would make patient data available for undefined research purposes, including CQI, to more than 2.2 million entities plus government agencies.
This is a dramatic shift away from today’s protections for human subjects. Under today’s federal “HIPAA privacy rule,” researchers have specific de-identification requirements and limitations on access and use. However, HIPAA requires no patient consent for access or use under “health care operations” (HCO) or “public health activities.”
Only people living in states with true (anti-HIPAA) medical privacy laws would be protected – but those states are rare.
The “Cures Act” also prohibits barriers to outsider access. Section 3001 mandates that electronic health record (EHR) companies, under threat of penalties, provide transfer of and access to “the entirety of a patient’s data form any and all health information technology for authorized use under applicable law.” As stated above, Section 1124 expands “authorized use” to unspecified “research.”
H.R. 6 also specifically includes the use of patient data for controversial “comparative effectiveness research” (CER) as established by Obamacare.
A reporter from The Hill (Washington, D.C.) asked me yesterday about the dangers of allowing such broad access to private patient data. I included the following:
  1. The end of the confidential patient-doctor relationship.
  2. Health care rationing as outsiders profile patients and doctors and use patient data to dictate treatment and conduct rationing-based research.
  3. Poor care as patients avoid the frank disclosures necessary for accurate and timely medical care.
  4. Inaccurate research findings as patients falsify data to protect themselves.
  5. Loss of public support for medical research and health care institutions as patients realize the research enterprise and the health care system do not respect their privacy rights, are interfering in treatment decisions, and are using their data for purpose they have no agreed to.
The bill may be hindered by its $13 billion price tag. But the impact on citizen and patient privacy and autonomy rights should also put a stop to passage until patient consent is required.
Protecting your health freedom by protecting privacy,
Twila Brase, RN, PHN
President and Co-founder
P.S. Tell Congress the proper cure for the “21st Century Cures Act” (H.R. 6) is informed patient consent requirements. (switchboard: 202-224-3121)