Comprehensive AI Risk

Management Framework for

Healthcare

Atika Kumar
Founder & Digital Strategy Advisor
WiZTREE Consulting
Table of Contents
Comprehensive AI Risk Management Framework for Healthcare ..................................................................... 2
Purpose ...................................................................................................................................................................... 2
Components ............................................................................................................................................................... 2
1. AI Risk Assessment Questionnaire ..................................................................................................................... 2
Data and Model Bias ....................................................................................................................................... 2
Privacy and Data Protection ............................................................................................................................ 2
Accuracy and Reliability .................................................................................................................................. 2
Transparency and Explainability ..................................................................................................................... 3
Automation Bias and Human Factors.............................................................................................................. 3
Workforce Impact............................................................................................................................................. 3
Cybersecurity ................................................................................................................................................... 3
Regulatory Compliance.................................................................................................................................... 3
Ethical Concerns .............................................................................................................................................. 4
Environmental Impact ..................................................................................................................................... 4
Accessibility and Equity ................................................................................................................................... 4
Misinformation and Trust ................................................................................................................................ 4
Integration and Interoperability ...................................................................................................................... 4
Legal Liability .................................................................................................................................................. 4
2. Impact Assessment Matrix .................................................................................................................................. 5
3. Probability Evaluation ......................................................................................................................................... 5
4. Risk Scoring and Prioritization ........................................................................................................................... 5
5. Mitigation Strategy Development ...................................................................................................................... 5
6. Monitoring and Review Process ......................................................................................................................... 6
Implementation Guidelines ....................................................................................................................................... 6
Appendix: Glossary of Key Terms ............................................................................................................................. 6

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Comprehensive AI Risk Management Framework for
Healthcare
Purpose
To identify, assess, and mitigate risks associated with AI implementation in healthcare settings, with a
focus on large multi-modal models (LMMs) and other AI technologies.

Components
1. AI Risk Assessment Questionnaire
For each question, choose the most appropriate answer: A) No risk - This is not a concern in our context
B) Low risk - Minimal concern, existing measures are likely sufficient C) Medium risk - Notable concern,
may require additional measures D) High risk - Significant concern, requires immediate attention E) Not
applicable - This doesn't apply to our AI implementation

Data and Model Bias

1. Is there a risk of underrepresentation of specific patient populations in the training data? A) No

risk B) Low risk C) Medium risk D) High risk E) Not applicable
2. Could historical biases (e.g., racial, gender, or age) in medical data affect the AI model? A) No
risk B) Low risk C) Medium risk D) High risk E) Not applicable
3. Is there a possibility of contextual bias if the AI is applied in settings different from its training
environment? A) No risk B) Low risk C) Medium risk D) High risk E) Not applicable
4. Could bias in model outputs lead to unfair treatment recommendations for certain groups? A)
No risk B) Low risk C) Medium risk D) High risk E) Not applicable

Privacy and Data Protection

5. Is there a risk of unauthorized access to patient data used in AI training? A) No risk B) Low risk
C) Medium risk D) High risk E) Not applicable
6. What is the likelihood of re-identification in anonymized datasets used by the AI? A) No risk B)
Low risk C) Medium risk D) High risk E) Not applicable
7. Could LMMs unintentionally disclose sensitive patient information? A) No risk B) Low risk C)
Medium risk D) High risk E) Not applicable
8. Are there potential compliance issues with data protection regulations (e.g., GDPR, HIPAA)? A)
No risk B) Low risk C) Medium risk D) High risk E) Not applicable

Accuracy and Reliability

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 9. What is the potential for false positives/negatives in AI-assisted diagnoses? A) No risk B) Low
risk C) Medium risk D) High risk E) Not applicable
10. Could the AI perform inconsistently across different patient subgroups? A) No risk B) Low risk C)
Medium risk D) High risk E) Not applicable
11. Is there a risk of "hallucinations" or fabricated information in LMM outputs? A) No risk B) Low
risk C) Medium risk D) High risk E) Not applicable
12. How likely is the degradation of model performance over time? A) No risk B) Low risk C)
Medium risk D) High risk E) Not applicable

Transparency and Explainability

13. Is there a risk of "black box" decision-making in critical care situations? A) No risk B) Low risk C)
Medium risk D) High risk E) Not applicable
14. How difficult would it be to audit AI-assisted medical decisions? A) No risk B) Low risk C)
Medium risk D) High risk E) Not applicable
15. Is there a lack of interpretability in AI-generated treatment plans? A) No risk B) Low risk C)
Medium risk D) High risk E) Not applicable

Automation Bias and Human Factors

16. Is there a risk of healthcare professionals over-relying on AI recommendations? A) No risk B)

Low risk C) Medium risk D) High risk E) Not applicable
17. Could the use of AI lead to diminished critical thinking skills among medical staff? A) No risk B)
Low risk C) Medium risk D) High risk E) Not applicable
18. Is there a possibility of reduced human oversight in AI-driven processes? A) No risk B) Low risk
C) Medium risk D) High risk E) Not applicable

Workforce Impact

19. Is there a risk of job displacement in specific medical specialties due to AI? A) No risk B) Low
risk C) Medium risk D) High risk E) Not applicable
20. Could AI adoption lead to skills obsolescence and need for continual retraining? A) No risk B)
Low risk C) Medium risk D) High risk E) Not applicable

Cybersecurity

21. How vulnerable are the AI systems to adversarial attacks? A) No risk B) Low risk C) Medium risk
D) High risk E) Not applicable
22. Is there a risk of data poisoning during model updates or fine-tuning? A) No risk B) Low risk C)
Medium risk D) High risk E) Not applicable
23. What is the likelihood of unauthorized model access or theft? A) No risk B) Low risk C) Medium
risk D) High risk E) Not applicable

Regulatory Compliance

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 24. Is the regulatory status of the AI/LMM application unclear (medical device vs. wellness app)? A)
No risk B) Low risk C) Medium risk D) High risk E) Not applicable
25. Are there challenges in obtaining regulatory approval for adaptive AI models? A) No risk B) Low
risk C) Medium risk D) High risk E) Not applicable

Ethical Concerns

26. Could AI intermediation erode the patient-doctor relationship? A) No risk B) Low risk C) Medium
risk D) High risk E) Not applicable
27. Is there a risk of reduced patient autonomy in AI-influenced decision-making? A) No risk B) Low
risk C) Medium risk D) High risk E) Not applicable
28. Are there challenges in obtaining informed consent for AI use in patient care? A) No risk B) Low
risk C) Medium risk D) High risk E) Not applicable

Environmental Impact

29. Is the energy consumption for training and running AI models excessively high? A) No risk B)
Low risk C) Medium risk D) High risk E) Not applicable
30. Could AI implementation lead to excessive water usage in data centers? A) No risk B) Low risk
C) Medium risk D) High risk E) Not applicable

Accessibility and Equity

31. Is there limited availability of AI tools in low-resource settings? A) No risk B) Low risk C)
Medium risk D) High risk E) Not applicable
32. Could language barriers in AI interfaces and outputs exclude certain patient groups? A) No risk
B) Low risk C) Medium risk D) High risk E) Not applicable

Misinformation and Trust

33. What is the potential for spread of AI-generated medical misinformation? A) No risk B) Low risk
C) Medium risk D) High risk E) Not applicable
34. Could AI mistakes lead to erosion of trust in healthcare institutions? A) No risk B) Low risk C)
Medium risk D) High risk E) Not applicable

Integration and Interoperability

35. Are there compatibility issues between AI systems and existing electronic health records? A) No
risk B) Low risk C) Medium risk D) High risk E) Not applicable
36. Could there be challenges in integrating AI outputs into clinical workflows? A) No risk B) Low
risk C) Medium risk D) High risk E) Not applicable

Legal Liability

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 37. Is there unclear responsibility for AI-related medical errors? A) No risk B) Low risk C) Medium
risk D) High risk E) Not applicable
38. Are there challenges in applying traditional malpractice frameworks to AI use? A) No risk B) Low
risk C) Medium risk D) High risk E) Not applicable

2. Impact Assessment Matrix

Impact
Description Score
Level
Severe harm to patients, major legal/regulatory violations, or significant system-
Critical 5
wide disruption
Considerable adverse effects on patient care, notable legal/regulatory issues, or
High 4
substantial operational impact
Moderate impact on patient care, potential legal/regulatory concerns, or noticeable
Medium 3
operational disruption
Minor impact on patient care, limited legal/regulatory risk, or slight operational
Low 2
inconvenience
Negligible Minimal or no impact on patient care, operations, or legal/regulatory standing 1

3. Probability Evaluation

Probability Level Description Score

Very Likely Expected to occur in most circumstances 5
Likely Will probably occur in most circumstances 4
Possible Might occur at some time 3
Unlikely Could occur at some time 2
Rare May occur only in exceptional circumstances 1

4. Risk Scoring and Prioritization

1. For each risk identified in the questionnaire (answers C or D), assign an impact score and
probability score using the matrices above.
2. Calculate the risk priority score: Risk Priority = Impact Score × Probability Score
3. Rank risks based on their priority scores.

5. Mitigation Strategy Development

For each identified risk, especially those with high priority scores:

1. Develop mitigation strategies, considering:

o Technical measures (e.g., improved data quality, model fine-tuning)

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 o Procedural controls (e.g., human oversight, audit processes)
o Organizational policies (e.g., ethical guidelines, staff training)
o Legal and regulatory compliance measures
2. Assign responsibility for implementation
3. Set timeline for implementation and review

6. Monitoring and Review Process

• Establish key performance indicators (KPIs) for each mitigation strategy
• Conduct regular audits and impact assessments
• Implement a continuous feedback loop from healthcare professionals and patients
• Stay updated on evolving AI technologies and regulatory landscapes
• Review and update the risk management framework annually or when significant changes occur

Implementation Guidelines
1. Form a multidisciplinary team including AI experts, healthcare professionals, ethicists, and legal
advisors
2. Conduct the initial risk assessment using the AI Risk Assessment Questionnaire
3. Use the Impact Assessment Matrix and Probability Evaluation to score identified risks
4. Prioritize risks based on their scores
5. Develop mitigation strategies for high-priority risks
6. Implement mitigation strategies and monitor their effectiveness
7. Ensure transparency in AI decision-making processes
8. Provide adequate training for healthcare staff on AI systems and associated risks
9. Maintain open communication channels with regulatory bodies and stay compliant with
evolving regulations
10. Engage in public dialogue and patient education about AI use in healthcare
11. Collaborate with AI developers to address identified risks and improve systems
12. Document all risk management activities and decisions for accountability and future reference
13. Regularly review and update the risk assessment and mitigation strategies

Appendix: Glossary of Key Terms

• AI: Artificial Intelligence
• LMM: Large Multi-Modal Model
• GDPR: General Data Protection Regulation
• HIPAA: Health Insurance Portability and Accountability Act
• KPI: Key Performance Indicator