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- TL;DR
- Increased involvement of DNA sequences and associated technologies in medical decisions will generate new legal confrontations.
As DNA sequence information from individual patients becomes more available, and the amount of information associated with particular sequence variants increases, this kind of collection and analysis of sequence data will assume great importance to medical practitioners.
With medical importance comes legal stuff.
This news article from Science reviews a recent symposium the recently developed overlap of DNA sequencing and analysis technologies and the legal impacts of its use in medicine.
When something goes wrong... Who (if anyone) is responsible for what? (In order to sue them)
A key term seems to be "standard of care", which defines legally how far a particular part of the medical world has to go to have met the standard of care, in case something goes wrong. (Triggering a suit.)
Its not clear what that standard of care would be for testing companies in some scenarios.
The S. Carolina supreme court decided a testing lab should be considered as a health care provider, which will presumably require compliance with an increased set of regulations.
Since this is a new, rapidly changing field, the state of knowledge also rapidly changes, and
there are not a lot of precedents yet.
Some of the problems under consideration are:
Changes in knowledge about sequences variants long after a test was given.
Few significant rulings have yet been made, but conflict is anticipated,
due to the looming confrontation of opposing legal interests
(patients vs. various medical practitioners/companies).
As a result, some want new rules or laws, so they know what to comply with, and can move on to other things.
With medical importance comes legal stuff.
This news article from Science reviews a recent symposium the recently developed overlap of DNA sequencing and analysis technologies and the legal impacts of its use in medicine.
When something goes wrong... Who (if anyone) is responsible for what? (In order to sue them)
A key term seems to be "standard of care", which defines legally how far a particular part of the medical world has to go to have met the standard of care, in case something goes wrong. (Triggering a suit.)
Its not clear what that standard of care would be for testing companies in some scenarios.
The S. Carolina supreme court decided a testing lab should be considered as a health care provider, which will presumably require compliance with an increased set of regulations.
Since this is a new, rapidly changing field, the state of knowledge also rapidly changes, and
there are not a lot of precedents yet.
Some of the problems under consideration are:
Changes in knowledge about sequences variants long after a test was given.
• a new sequence variant is identified, but nothing is known about it
• later, it is linked with some disease condition (or perhaps in combination with another separate sequence); or any other related update in the scientific literature.
Recontacting test subjects (patients) from previous tests, when new information comes to light about the good or badness of a particular sequence variant.• patient moved, leaving no contact information
Few significant rulings have yet been made, but conflict is anticipated,
due to the looming confrontation of opposing legal interests
(patients vs. various medical practitioners/companies).
As a result, some want new rules or laws, so they know what to comply with, and can move on to other things.
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