Why Startups Can't Afford to Skip HIPAA
Healthcare startups handling patient data face the same HIPAA obligations as established providers. Violations can result in fines from $100 to $1.5 million per violation category—and reputational damage that can sink a young company. Starting with compliance built in is far easier than retrofitting later.
HIPAA Compliance Checklist
1. Determine Your Status
Are you a covered entity (health plan, healthcare provider, healthcare clearinghouse) or a business associate? If you create, receive, maintain, or transmit PHI on behalf of a covered entity, you're a business associate and need a BAA.
2. Designate Privacy and Security Officers
Assign individuals responsible for HIPAA compliance. For startups, one person may handle both roles initially, but document the responsibility.
3. Conduct a Risk Assessment
Identify where PHI flows through your systems, who has access, and what risks exist. Document findings and remediation plans. Repeat annually or when significant changes occur.
4. Implement Policies and Procedures
Develop written policies covering: workforce training, access management, breach notification, incident response, and physical/technical safeguards. Tailor them to your specific operations.
5. Execute Business Associate Agreements
Sign BAAs with every vendor that handles PHI: cloud hosts, email providers, analytics tools, payment processors, CRM platforms. No BAA, no PHI.
6. Train Your Team
All workforce members with PHI access must complete HIPAA training upon hire and annually thereafter. Document completion.
7. Implement Technical Safeguards
Encryption (transit and rest), access controls, audit logging, secure authentication. See our technical requirements guide for details.
8. Prepare a Breach Response Plan
Define steps for detecting, containing, and reporting breaches. HIPAA requires notification within 60 days. Have templates and contacts ready.
Common Startup Mistakes
- Using Gmail, Slack, or Dropbox for PHI without BAA
- Assuming "we're a startup" exempts you from HIPAA
- Delaying compliance until after product launch
- Not documenting compliance efforts
Conclusion
HIPAA compliance for startups is achievable with early planning. Start with a risk assessment, sign BAAs with vendors, implement core technical safeguards, and document everything. Compliance is an ongoing process, not a one-time project.
Building a healthcare startup? Talk to us about HIPAA-compliant software development and healthcare technology solutions.
