Law / United States / 
Michigan
Genetic test; informed consent
In force.
A sensitive categories rule binding public and private bodies.
- Audit expectation
- none
What it requires
- Obtain a test subject's written, informed consent before a physician orders a presymptomatic or predictive genetic test in Michigan.
- Do not rely on this section to cover a direct-to-consumer genetic-testing company's privacy practices; no Michigan statute reaches that activity.
These lines are LexLint's reading of the law's text.
In the frameworks
- NIST Privacy Framework
- CT.PO-P1Policies, processes, and procedures for authorizing data processing (e.g., organizational decisions, individual consent), revoking authorizations, and maintaining authorizations are established and in place.
Our reading of where this law's duties sit in each framework. It never says that running a control meets the law. How we read a framework against the law
Who enforces it
Settledness
- As of
- Open questions
- Does a test that estimates a probability of disease, such as a polygenic risk score, count as a 'predictive genetic test' under MCL 333.17020(8)(c) when subsection (8)(b) limits a 'genetic test' to one 'generally accepted in the scientific and medical communities as being specifically determinative for the presence, absence, or mutation of a gene or chromosome'?
What it makes you log
What the log must hold
Consent or opt-out state
Logging duty
A physician may not order a presymptomatic or predictive genetic test without the test subject's written, informed consent, a signed writing. Where the subject signs the department's model form, the physician gives the subject a copy and includes the original signed form in the subject's medical record, so the consent is kept as a record. The section sets no retention period of its own, names no audit and has no territorial clause. The subject's copy of the signed form is coded as access by the data subject.
- Kind
- Implicit
- As of
- Provision
- MCL 333.17020(5)
- Trigger
- consent_or_optout
What this law does
A physician, or an individual to whom the physician has delegated authority to perform a selected act, task, or function, may not order a presymptomatic or predictive genetic test without first obtaining the test subject's written, informed consent.
This is a health-care informed-consent requirement binding a physician's ordering conduct, not a consumer-facing data-privacy or data-processing statute, and it does not reach a direct-to-consumer genetic-testing company; no Michigan statute regulates such a company's privacy practices. The act that added this section, Act 29 of 2000, took immediate effect on , and the consent requirement begins upon the expiration of 6 months after that date; no source states the resulting day.
When LexLint raises it
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