Navigating HIPAA Compliance In Tech Startups

7 security and governance steps I recommend for AI-powered health-tech startups to avoid hacks and fines: 1. Pick a framework -> The Health Insurance Portability and Accountability Act (HIPAA) is non-negotiable if you handle protected health information (PHI). Look at the security, privacy, and data breach notification rule requirements. -> If you want a certification (incl. addressing HIPAA requirements), HITRUST is a good place to start due to origins in healthcare. The AI security certification gives you solid controls for these types of systems. -> If you are looking to cover responsible AI as well as security/privacy, ISO 42001 is a good option. Consider adding HIPAA requirements as additional Annex A controls. 2. Publish policies Longer != better. Use prescriptive statements like "Employees must XYZ." If there are detailed steps, delegate responsibility for creating a procedure to the relevant person. Note that ISO 42001 requires an "AI Policy." 3. Classify data Focus on handling requirements rather than sensitivity. Here are the classifications I use: -> Public: self-explanatory -> Public-Personal Data: still regulated by GDPR/CCPA -> Confidential-Internal: business plans, IP, etc. -> Confidential-External: under NDA with other party -> Confidential-Personal Data: SSNs, addresses, etc. -> Confidential-PHI: regulated by HIPAA, needs BAA 4. Assign owners Every type of data - and system processing it - needs a single accountable person. Assigning names clarifies roles and responsibilities. Never accept "shared accountability." 5. Apply basic internal controls This starts with: -> Asset inventory -> Basic logging and monitoring -> Multi-factor authentication (MFA) -> Vulnerability scanning and patching -> Rate limiting on externally-facing chatbots Focus on the 20% of controls than manage 80% of risk. 6. Manage 3rd party risk This includes both vendors and open source software. Measures include: -> Check terms/conditions (do they train on your data?) -> Software composition analysis (SCA) -> Service level agreements (SLA) 7. Prepare for incidents If your plan to deal with an imminent or actual breach is "start a Slack channel," you're going to have a hard time. At a minimum, determine in advance: -> What starts/ends an incident and who is in charge -> Types of incidents you'll communicate about -> Timelines & methods for disclosure -> Which (if any) authorities to notify -> Root cause analysis procedure TL;DR - here are 7 basic security and governance controls for AI-powered healthcare companies: 1. Pick a framework 2. Publish policies 3. Classify data 4. Assign owners 5. Apply basic controls 6. Manage 3rd party risk 7. Prepare for incidents What else?

The year’s ending, compliance risks aren’t. As the year winds down... There’s 1 thing health tech leaders should double-check. Your HIPAA compliance readiness. The stakes are too high during the holidays. Review these essentials before January: 1. Access Controls → Who can access patient data? → Are permissions still up to date? → Ensure RBA is enforced to limit exposure. 2. Vendor Agreements → Third-parties are an extension of your security. → Are your Business Associate Agreements airtight? 3. Risk Management → Have you conducted a recent risk assessment? → Have you conducted a recent HIPAA assessment? 4. Incident Response Plans → If a breach happens, can your team act fast? → Review and test your incident response plan. → Ensure it’s a playbook your team knows by heart. 5. Security Training → Your people are your first line of defense. → Have your teams completed annual HIPAA training? → Everyone must know how to protect patient data. 6. Documentation Updates → Regulations evolve. → So should your policies. → Are your privacy and security policies up to date? Compliance is about protecting what matters... Your patients Your reputation And your business. If any points leave you wondering, “Are we covered?” It might be time to partner with an expert. 𝗣.𝗦. Are you more concerned with vendors or training?

10 Steps and considerations for achieving HIPAA Compliance 1. Business Associate Agreement (BAA): If you're a covered entity or a business associate handling PHI, ensure that you sign a BAA. 2. Data Encryption: Enable encryption for data at rest and data in transit. 3. Access Controls: Utilize access control features to ensure that only authorized individuals can access PHI. This includes user authentication, role-based access controls, and implementing strong password policies. 4. Data Loss Prevention (DLP): Implement DLP policies to prevent unauthorized sharing of PHI. DLP policies can help monitor and prevent the transmission of sensitive data through email and other services. 5. Audit Logging and Monitoring: Enable audit logging and monitoring features to track access to PHI and detect any suspicious activities or security breaches. 6. Secure Email Communication: Use Exchange Online Protection (EOP) and Exchange Online to secure email communications containing PHI. 7. Mobile Device Management (MDM): Implement MDM policies to secure mobile devices that access PHI. This includes enforcing device encryption, remote wipe capabilities, and mobile app management. 8. Training and Awareness: Train employees on HIPAA requirements, security best practices. 9. Regular Risk Assessments: Conduct regular risk assessments to identify and address potential security vulnerabilities and compliance gaps. 10. Continual Monitoring and Improvement: HIPAA compliance is an ongoing process. Continually monitor your environment for compliance and security risks, and make improvements as needed. #DigitalHealth #EHR #HIPAA #HipaaCompliant #Telehealth #Telemedicine