1. Purpose

Software can count as a medical device when its intended purpose is medical, even if no physical device is involved. If Zebrold AI, or any function of it, counts as medical device software, it may need conformity assessment, CE marking and other steps in the European Union, and licensing or registration in India, before it can be used. This document records the facts and the questions that counsel needs to answer.

2. Description of Zebrold AI

3. Questions for assessment

4. Outcome

Until the assessment is signed off, Zebrold AI is used only for the functions described above, under the safeguards in the AI Use Policy (CYD-AI-01), and no marketing claim describes it as diagnosing, treating or preventing any disease.

5. How to reason about classification

The legal question depends on the intended purpose of the software as the company states it, and on what the software actually does, so the description of the functions above must be accurate and complete. In the European Union, software that provides information used to take decisions for diagnosis or treatment, or that monitors physiological processes, is generally treated as a medical device and is classified by the potential harm of a wrong output. Software that only stores, transfers or displays data, or that carries out simple administration, is often outside the rules. In India, the rules on medical devices apply to software that is intended to be used for medical purposes. Counsel should apply the current text of each law and the latest guidance of the regulators.

6. Evidence file to prepare

• A written statement of the intended purpose and the users of each function.
• Design documents, the data used and the way performance was tested.
• A risk analysis that considers wrong, missing and late outputs, and the harm that could follow.
• Clinical evidence that the function is safe and performs as stated, which can include literature and the company's own testing.
• The human oversight and instructions for use given to doctors and patients.
• The vendor's declarations and technical files, where the tool is bought in.

7. Action plan

8. Monitoring after launch

Whatever the outcome, the company monitors how the AI functions perform in use, records problems and complaints, and reports serious incidents to the regulators where the law requires. The assessment is repeated whenever a function changes, whenever a new function is proposed and at least once a year.

9. Scope and assumptions

This assessment covers the functions of Zebrold AI listed above as they exist at the date of the document. It assumes that the AI functions are used only by licensed doctors, pathologists and patients, and that no function gives a diagnosis, chooses a treatment or reduces the review of a doctor. If any of those assumptions changes, the assessment must be repeated before the change goes live.

10. Information needed from the technical team and vendors

• A description of how each function works, the inputs it uses and the outputs it creates.
• The data used to build and test the function, and the results of testing, including error rates.
• The version history, and how changes are controlled.
• The limits of use stated by the vendor, and any regulatory status that the vendor claims.
• The way the function behaves when the data is missing, wrong or unusual.

11. Other laws to consider

Besides medical device rules, the company considers data protection law, rules on telemedicine and on prescribing, consumer protection, rules on advertising of health services and professional rules for doctors. Claims made to patients and partners about Zebrold AI must be accurate and supported by evidence, and must not suggest that the software replaces a doctor.

12. Sign-off

13. Timeline for the assessment

1. Purpose

Software can count as a medical device when its intended purpose is medical, even if no physical device is involved. If Zebrold AI, or any function of it, counts as medical device software, it may need conformity assessment, CE marking and other steps in the European Union, and licensing or registration in India, before it can be used. This document records the facts and the questions that counsel needs to answer.

2. Description of Zebrold AI

3. Questions for assessment

4. Outcome

Until the assessment is signed off, Zebrold AI is used only for the functions described above, under the safeguards in the AI Use Policy (CYD-AI-01), and no marketing claim describes it as diagnosing, treating or preventing any disease.

5. How to reason about classification

The legal question depends on the intended purpose of the software as the company states it, and on what the software actually does, so the description of the functions above must be accurate and complete. In the European Union, software that provides information used to take decisions for diagnosis or treatment, or that monitors physiological processes, is generally treated as a medical device and is classified by the potential harm of a wrong output. Software that only stores, transfers or displays data, or that carries out simple administration, is often outside the rules. In India, the rules on medical devices apply to software that is intended to be used for medical purposes. Counsel should apply the current text of each law and the latest guidance of the regulators.

6. Evidence file to prepare

• A written statement of the intended purpose and the users of each function.
• Design documents, the data used and the way performance was tested.
• A risk analysis that considers wrong, missing and late outputs, and the harm that could follow.
• Clinical evidence that the function is safe and performs as stated, which can include literature and the company's own testing.
• The human oversight and instructions for use given to doctors and patients.
• The vendor's declarations and technical files, where the tool is bought in.

7. Action plan

8. Monitoring after launch

Whatever the outcome, the company monitors how the AI functions perform in use, records problems and complaints, and reports serious incidents to the regulators where the law requires. The assessment is repeated whenever a function changes, whenever a new function is proposed and at least once a year.

9. Scope and assumptions

This assessment covers the functions of Zebrold AI listed above as they exist at the date of the document. It assumes that the AI functions are used only by licensed doctors, pathologists and patients, and that no function gives a diagnosis, chooses a treatment or reduces the review of a doctor. If any of those assumptions changes, the assessment must be repeated before the change goes live.

10. Information needed from the technical team and vendors

• A description of how each function works, the inputs it uses and the outputs it creates.
• The data used to build and test the function, and the results of testing, including error rates.
• The version history, and how changes are controlled.
• The limits of use stated by the vendor, and any regulatory status that the vendor claims.
• The way the function behaves when the data is missing, wrong or unusual.

11. Other laws to consider

Besides medical device rules, the company considers data protection law, rules on telemedicine and on prescribing, consumer protection, rules on advertising of health services and professional rules for doctors. Claims made to patients and partners about Zebrold AI must be accurate and supported by evidence, and must not suggest that the software replaces a doctor.

12. Sign-off

13. Timeline for the assessment