Human Subjects Research - Major Revision Planned
The federal Food and Drug Administration (FDA) plans to make sweeping changes to federal regulations on human subjects research. In this response to the administration's request for public comments on their Advance Notice of Proposed Rulemaking, CCHF says data and DNA ownership as well as patient consent for access to and use of medical records and biospecimens collected from patients in clinics, hospitals and elsewhere is necessary. CCHF Opposes Proposed "Risk Scores" on Individuals
Citizens' Council for Health Freedom opposes this proposed federal rule, particularly the sweeping data collection plan, the mandate to create “risk scores” on individuals, the redistribution of funds that will likely lead to rationing of care, the fuzzy math that is “risk adjustment”, the “risk corridors” that will facilitate fuzzy math and fund transfers, and the power of the federal government to mandate reinsurance contributions by States. CCHF Opposes Proposed Health Insurance Exchange Regulation
In general, CCHF is opposed to the proposed exchange regulation, which requires States to set up a federal structure by which the federal government will control virtually all facets of health care nationwide (coverage and care). We conclude our public comments by asking HHS to withdraw the entire rule.
Public Responds to Federal Rationing Plan
The Patient Centered Outcomes Research Institute (PCORI), established under Obamacare, asked the American public to comment on the Institute's definition of "patient-centered outcomes research." The deadline was Friday, September 2. Many CCHF supporters responded. In short, PCORI's definition is deceptive and leaves the public thinking that PCORI (pronounced "pea-CORE-ee") is going to do great work. However, the controversial "comparative effectiveness research" will be used by the federal government to make insurance coverage decisions for all citizens. CCHC Opposes HHS' Lack of Consent for State Retention of Baby DNACCHF responds to HHS Request for Public Comments on “Considerations and Recommendations for National Guidance Regarding the Retention and Use of Residual Dried Blood Spot Specimens after Newborn Screening,” – a Briefing Paper issued April 26, 2010 by HHS through the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children. CCHC Opposes Rescission of Practitioner Freedom of Conscience ClauseNo patient, no government official, no policymaker should be able to require a practitioner to do what is viewed as unethical, morally objectionable or a violation of the religious beliefs of that practitioner. CCHC Opposes Proposed "National Health Information Network"The HHS notice states, “Regardless of how it is developed, overseen or operated, there is a compelling public interest for a NHIN to exist.” This claim does not stand up to scrutiny. Nor is it supported by any documentation. There is no evidence that the public is asking for a national electronic medical records system that will facilitate the sharing and dissemination of their private medical records. CCHC Testifies Against Mandatory Genetic Testing of NewbornsIt is particularly concerning that this major initiative has been placed within a very contentious budget bill. Having it in this bill means that it is less likely to receive the discussion it needs before passage is even considered. Proposed Federal Guidance Threatens Patient Access to MedicationImportantly, in the drive to limits federal payments for pharmaceuticals, the guidance may lead to limited access to medication for all citizens, not just those patients in federal programs. CCHC's Public Comments on Medical PrivacyThe federal government does not have the legal or moral authority to strip individuals of basic patient rights in order to achieve faster transactions, more convenience, or any other stated rationale. In fact the implementation of the medical privacy rule is an infringement of federalism, to say nothing of Fourth amendment rights. Donate Today!
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Health Privacy Alert!
HIPAA DOES NOT PROTECT PRIVACY... AND YOU ARE By federal law, you are not required to sign the clinic or hospital HIPAA "Privacy" form (or the Acknowledgement of the Notice of Privacy Practices embedded in consent forms)...even if the clinic tries to insist that you must.
ACA - "Obamacare"
Medical or Health Care Sharing
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Baby DNA Warehousing
Health Insurance Exchange
REAL ID - Federal Control
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