Generative artificial intelligence (AI) is being implemented throughout the healthcare industry to assist with innovation and improvement in patient care. This technology also brings forth a set of legal considerations that healthcare technology companies must carefully navigate to ensure compliance and mitigate risks. This post provides a high level overview of legal issues healthcare technology companies must address when utilizing generative AI.
1. Data Privacy and Security
Healthcare technology companies must comply with various data protection laws that are both industry and jurisdiction-specific, such as the Health Insurance Portability and Accountability Act (HIPAA) in the United States, the General Data Protection Regulation (GDPR) in the European Union, and the myriad of state laws across the United States. These laws mandate stringent requirements for the collection, storage, processing, and sharing of personal health information (PHI) and sensitive personal information.
Key Considerations:
- Data Minimization: Ensure that only necessary data is collected and processed.
- Anonymization and De-identification: Implement techniques to anonymize or de-identify patient data, reducing the risk of privacy breaches.
- Security Measures: Adopt robust cybersecurity measures to protect data against unauthorized access, breaches, and cyberattacks.
2. Compliance with Medical Regulations
The use of AI in healthcare is subject to regulation by entities such as the U.S. Food and Drug Administration (FDA), the Department of Health and Human Services (HHS), and state commissions on data privacy.
Key Considerations:
- Classification and Approval: Determine whether the generative AI application is classified as a medical device. If so, it must undergo the FDA’s approval process, which includes demonstrating safety and efficacy.
- Post-Market Surveillance: Implement systems for monitoring the performance of AI tools post-deployment to identify and mitigate any risks that arise.
3. Intellectual Property (IP) Issues
Protecting the intellectual property generated by AI is an important topic that is ever-changing with recent litigation.
Key Considerations:
- Patentability: Assess whether AI-assisted inventions meet the criteria for patent protection. The U.S. Patent and Trademark Office (USPTO) has specific guidelines for these patents, and while AI-generated materials cannot be patented – the use of AI by humans is not prohibited.
- Ownership: Clearly define ownership rights of AI-generated works, especially when collaborating with external partners or using third-party AI tools.
- Licensing: Ensure that any AI technology used is properly licensed and that the terms of use are adhered to.
- Use of Output: Ensure that you have all necessary rights to utilize the output from generative AI features to provide services to your users.
4. Liability and Accountability
The deployment of AI in healthcare raises complex liability issues, especially when AI-generated decisions impact patient outcomes.
Key Considerations:
- Risk Management: Develop comprehensive risk management strategies to address potential AI failures or inaccuracies.
- Clear Accountability: Establish clear lines of accountability within the organization for AI-related decisions and outcomes.
- Insurance: Consider obtaining specialized insurance coverage to protect against AI-related liabilities.
5. Ethical Considerations
While not strictly legal, ethical considerations are closely tied to regulatory compliance and public trust.
Key Considerations:
- Bias and Fairness: Implement measures to detect and mitigate biases in AI algorithms to ensure fair and equitable treatment of all patients.
- Transparency: Maintain transparency in AI decision-making processes to build trust with patients and stakeholders.
- Informed Consent: Ensure that patients are fully informed about the use of AI in their care and obtain their consent.
LET US HELP
This is a high level overview of considerations for healthcare technology companies utilizing generative AI, and is not meant to be comprehensive. If you need further assistance, feel free to reach out. We’ll discuss your specific needs and help you through the process.
This post is not legal advice, and does not establish any attorney client privilege between Law Office of K.S. Kader, PLLC and you, the reader. The content of this post was assisted by generative artificial intelligence solutions.