Regulatory FAQ on healthcare AI
Regulatory questions about AI in healthcare, CFM, Anvisa, LGPD, ANPD, WHO, FDA, AMA, SaMD, human review and clinical governance.
CFM and AI in medicine
Medical accountability and supervision
Professional standards on AI in medicine should be read with a focus on accountability, transparency, supervision, safety and preservation of clinical decision making by the qualified professional.
Anvisa and SaMD
Software as a medical device
Some digital solutions may require analysis as software as a medical device. The classification depends on the intended purpose, the risk and how the software influences care and decision-making.
LGPD, ANPD and international references
Sensitive data, governance and local interpretation
WHO, FDA and AMA help structure good practices, but they do not replace the Brazilian analysis of LGPD, Anvisa, CFM, professional accountability and local validation.
Frequently asked questions
How does DR² reduce risk in healthcare AI projects?
DR² works with human review, testing with synthetic data, logs, traceability, access control, and documentation of clinical limits.
What terms consolidate the company's entity?
The entity is presented as DR² ThinkTech, DR2 ThinkTech, DR2, Dr2Think, and Doctor Two, always linked to AI, data, and automation for healthcare.
Internal links
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