Reject Patient Research Without Consent

ST. PAUL, Minn.—Citizens’ Council for Health Freedom (CCHF, http://www.cchfreedom.org), a Minnesota-based national organization dedicated to preserving patient-centered health care and protecting patient and privacy rights, is calling on Rep. Fred Upton, chair of the House Energy & Commerce Committee, to table proposals that will allow Americans to be used as research subjects without their consent.

According to a report by the Committee, the 21st Century Cures bill will attempt to link science and the regulation of therapies to treat patients and diseases more quickly and effectively. The well-intentioned ends, though, would come with a significant blow to patient rights, says CCHF president and co-founder Twila Brase.

“The Cures Act (Subtitle G, section 1124) would authorize potentially millions of outsiders to have access to private patient records without patient consent,” Brase said. “The bill would define research using our private health data (e.g. medical, medication, behavioral, genetic, mental health) as ‘public health activities’ and ‘health care operations,’ meaning no patient consent would be required for access, per the HIPAA ‘no privacy’ rule.

“In short,” Brase said, “hospitals, doctors, clinics, health plans, and data clearinghouses, as well as 1.5 million business associates engaged in ‘health care operations’ and all government agencies engaged in ‘public health activities’ would be given access to our medical records for analysis and research. It’s a boon for corporate and government interests.

“This is not progress as the title ‘21st Century Cures’ suggests; this would be a major step backwards for the privacy and consent rights of human subjects,” Brase continued. “By eliminating certain protective requirements for research currently in HIPAA, this initiative essentially turns all Americans into involuntary research subjects.”

The House Energy and Commerce Health Subcommittee advanced the bill last week, and the full Committee will consider it this week. But CCHF says lawmakers are ignoring the bill’s privacy threats and dismissing patient privacy rights.

“The Cures Act not only authorizes use of private data without patient consent, it also requires electronic health records to provide access to the ‘entirety’ of the patient’s data,” Brase said.

“We’re calling on lawmakers and leadership to delete sections that infringe on the freedoms and privacy of Americans and to require informed written consent before anyone sees our medical records for any purposes—research or otherwise.”

CCHF says additional concerns with the initiative include:

Plans to establish a “third-party scientific research sharing system for trials solely funded by the federal government in order to allow the use and analysis of data beyond each individual research project.”

New federal surveillance system for neurological diseases such as “Parkinson’s disease and Multiple Sclerosis.”

Deeming the Secretary’s “pilot demonstrations” as “public health activities, permitting the use and disclosure of protected health information” without consent.

Exempting clinical trials subject to the Federal Food, Drug and Cosmetic Act (FFDCA) from human subjects requirements under the federal Common Rule.

Waiving informed consent requirements when the Secretary decides the clinical testing “poses no more than minimal risk to the human subject.”

Without consent requirements, calls for the “ability to share research and clinical data,” led by the Office of the National Coordinator (ONC) for Health Information Technology, which is pushing a nationwide plan for the interoperability of electronic health records.

Penalties for individuals/vendors charged with “blocking or otherwise inhibiting the flow of patient information throughout our healthcare system.”

“We are alarmed that Congress wants to classify health data research as ‘health care operations’ and ‘public health activities,’ which means all sorts of people could use this data without consent,” Brase said. “In short, the Cures bill as passed by the subcommittee would essentially create a free-for-all into everyone’s private health information.”

The American Hospital Association has also come out against the bill, with a representative telling Politico Pro that the proposed 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.”

For more information about CCHF and its “5C” Solution for Health Care, visit its web site at http://www.cchfreedom.org, its Facebook page at http://www.facebook.com/cchfreedom or its Twitter feed, @CCHFreedom.

Citizens’ Council for Health Freedom, a patient-centered national health freedom organization based in St. Paul, Minn., exists to protect health care choices and patient privacy. CCHF sponsors the daily, 60-second radio feature, Health Freedom Minute, which airs on approximately 350 stations nationwide, including 200 on the American Family Radio Network and 100 on the Bott Radio Network. Listeners can learn more about the agenda behind health care initiatives and steps they can take to protect their health care choices, rights and privacy.

CCHF president and co-founder Twila Brase, R.N., has been called one of the “100 Most Powerful People in Health Care” and one of “Minnesota’s 100 Most Influential Health Care Leaders.” A public health nurse, Brase has been interviewed by CNN, Fox News, Minnesota Public Radio, NBC Nightly News, NBC’s Today Show, NPR, New York Public Radio, the Associated Press, Modern Healthcare, TIME, The Wall Street Journal, The Washington Post and The Washington Times, among others. She is at the forefront of informing the public of crucial health issues, such as intrusive wellness and prevention initiatives in Obamacare, patient privacy, informed consent, the dangers of “evidence-based medicine” and the implications of state and federal health care reform.