The Minnesota Department of Health (MDH) will designate certain treatment protocols as the MN standard of care. At their own discretion, they will decide which protocols will be called “evidence-based” and approved for use. MDH will collect data on physician adherence to these government-issued protocols and publicly report compliance rates on their website. Physi- cians with low compliance rates may be financially penalized.
The so-called “Federal Medical Privacy Rule” (45 CFR Parts 160/164) —from the 1996 Health Insurance Portability and Accountability Act (HIPAA)—permits broad use and disclosure of individually-identifiable “protected health information” without patient consent. It is often referred to as the “HIPAA Privacy Rule” or just “HIPAA.” Minnesota’s medical privacy law (M.S. 144.335) more often requires patient consent before use and disclosure (see also M.S. 62J.55).
The federal HIPAA "Privacy" Rule allows broad use and disclosure of private medical records without patient consent. Specifically, no consent is required for 12 National Priority Purposes, including law enforcement and public health, or for Payment, Treatment and Health Care Operations. The definition of "Health Care Operations" is 390 words long.
People may not understand…that tissue samples they provide may be used for genetic research…They may believe that samples will be discarded after testing, although the law often requires that samples be retained. When samples are obtained as part of medical care, patients may not be told about the possibility that these samples will be stored and used for research.
Minnesota state law denies most consent rights for patients regarding use of their individually-identifiable medical records for medical research. UPDATE: Until the Minnesota Genetic Privacy Act passed in 2006, Minnesota law was silent on collection, storage use and dissemination of genetic information for genetic research. States are not preempted by federal law from passing stronger, more privacy-protecting laws.