GermanyGenetic Diagnostics Act (GenDG), Genetic Examinations, Genetic Samples and Data, and Genetic Discrimination in Insurance and Employment
Gendiagnostikgesetz (GenDG) vom 31. Juli 2009 (BGBl. I S. 2529, 3672), as amended
In force since .
A sensitive categories rule binding public and private bodies.
- Obligation class
- Consent, Retention, Prohibition
- Audit expectation
- none
What it requires
- If you are a physician, or a laboratory a physician commissions, and you carry out a genetic examination or analysis, obtain the person's express written consent before the examination or the taking of the sample, after you have explained its nature, significance and scope and allowed reasonable time to decide (GenDG Sections 8 and 9).
- Keep the results of a genetic examination or analysis in the examination records for ten years, destroy them without delay once that period ends or where the person decided they are to be destroyed, and destroy a genetic sample without delay once it is no longer needed for its purpose or consent is withdrawn (Sections 12 and 13).
- If you are an insurer, do not demand a genetic examination or analysis, and do not demand, accept or use the results of earlier ones, before or after the contract, except for the results-based bar in life, occupational disability, earning-capacity and care annuity insurance above EUR 300,000 of benefit or EUR 30,000 of annual pension (Section 18).
- If you are an employer, do not demand a genetic examination or analysis of an employee, or demand, accept or use the results of earlier ones, before or after the employment begins, and do not disadvantage anyone because of their own or a relative's genetic characteristics (Sections 19 and 4).
These lines are LexLint's reading of the law's text.
If you get it wrong
Criminal exposureYes
Criminal exposure note
Carrying out a genetic examination or analysis without the consent GenDG Section 8(1) requires is punishable under Section 25(1) by imprisonment of up to one year or a fine.
What it makes you log
Logging duty
The Act requires the physician to document the content of the information given before an examination and an oral withdrawal of consent, and requires technical and organizational measures against unauthorized use of a sample (Section 13, paragraph 3). It requires no log of access to or processing of genetic data.
- Kind
- None
- As of
What this law does
The Act governs genetic examinations and genetic analyses of born people and of embryos and fetuses, and the handling of the samples and genetic data they yield, for medical purposes, to establish parentage, in insurance and at work, and it does not apply to research or to examinations under criminal-procedure, police or infection-control rules.
A diagnostic genetic examination may be carried out only by physicians, and a predictive one only by specialists in human genetics or physicians with a qualification for genetic examinations. An examination or analysis, and the taking of the sample it needs, requires the person's express written consent to the responsible physician, which also covers the processing of the genetic data, and the person may withdraw it at any time with effect for the future.
Before consent the physician must explain the nature, significance and scope of the examination and allow reasonable time to decide. The physician keeps the results in the examination records for ten years, and a sample may be used only for the purposes for which it was obtained and must be destroyed without delay once it is no longer needed for them or consent is withdrawn.
An insurer may not, before or after the contract, demand a genetic examination or analysis, or demand, accept or use the results of earlier ones, although the bar on results does not apply to life, occupational disability, earning-capacity and care annuity insurance where the benefit agreed exceeds EUR 300,000 or an annual pension of EUR 30,000.
An employer may not, before or after the employment begins, demand a genetic examination or analysis, or demand, accept or use the results of earlier ones, and no one may be disadvantaged because of their own genetic characteristics or those of a genetically related person.
Carrying out an examination or analysis without the required consent is punishable by imprisonment of up to one year or a fine, and listed breaches of the Act's other duties carry a fine of up to EUR 50,000, which does not apply where the General Data Protection Regulation (GDPR) applies directly.
When LexLint raises it
When your app profile says your app handles health records or processes personal data.
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