Lisa ANVISA Ready
Clinical safety and regulatory compliance
AI that respects medical guidance. Lisa communicates, explains and reinforces only guidance previously documented by licensed professionals. It does not diagnose, prescribe or determine treatment.
About the initiative
What Lisa ANVISA Ready means
Lisa ANVISA Ready is an internal initiative of regulatory readiness and continuous improvement at Lisa Discovery. It guides how we design, review and operate Lisa. It is not a certification, nor an approval by ANVISA.
Design principles
Commitments that guide Lisa
Medical autonomy
Lisa is designed so clinical decisions remain with licensed professionals.
Documented medical source
Communications are intended to be based on prescriptions and guidance already recorded by the care team.
Fidelity to guidance
Our commitment: no autonomous change to medication, dose or clinical conduct.
Human oversight
Content is meant to be approved by people, and out-of-scope questions are referred to the care team.
Security and traceability
We pursue information protection, access controls and a history of communications.
What Lisa does
- Communicates and makes more accessible what the professional has already advised
- Reinforces formalized instructions
- Refers questions that go beyond the documented source
What Lisa does not do
- Prescribe
- Diagnose
- Adjust doses
- Recommend new treatments
- Replace healthcare professionals
Regulatory approach
Our regulatory approach
We follow ANVISA's RDC 657/2022 on software as a medical device and the agency's official guidance, which distinguishes software that makes a prescription from software that communicates a prescription made by a physician.
Regulatory classification depends on the actual purpose and functioning of the product. We assess Lisa's features continuously against these criteria. Personal data is handled in line with Brazil's LGPD (Law 13.709/2018).
Lisa ANVISA Ready is an in-house initiative of regulatory assessment and readiness. It does not represent a certification, authorization, registration or approval granted by ANVISA. The applicability of requirements depends on the actual purpose and features.
Questions about clinical safety?
We are happy to explain how Lisa works and what it does not do.
Talk to our team