HealthTech 101: HIPAA and How to Comply in 10 Easy Steps

When you’re launching a healthtech startup, you’re not just creating software—you’re stepping into one of the most regulated industries in the world. If your product touches Protected Health Information (PHI), HIPAA compliance isn’t optional. It’s the baseline for trust, credibility, and growth.
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That’s where these steps comes in. It’s built specifically for healthcare innovation teams who want to do things right from day one—without getting lost in legal jargon:

• First things first: figure out whether you're a Covered Entity or a Business Associate. Most healthtech startups fall into the second category, which still holds you fully accountable for HIPAA compliance.
• Designate someone to take ownership of your HIPAA program. They’ll oversee documentation, training, risk assessments, and vendor management.
• This is your foundation. Identify where PHI is stored, how it moves, and where vulnerabilities lie. A solid risk assessment helps prevent issues before they escalate.
• Your policies should outline how your team accesses, stores, and shares sensitive data. Include protocols for everything—from login procedures to handling data breaches.
• Everyone, not just engineers or admins, should understand HIPAA basics. Incorporate training into onboarding and refresh it regularly to reflect any changes.
• Every third-party provider who handles PHI—think cloud storage, payment processors, analytics platforms—needs a signed Business Associate Agreement.
• Use technical safeguards like access restrictions, strong encryption, and secure authentication. These aren’t just best practices—they’re expected.
• Keep tabs on who’s accessing PHI and when. Set up audit logs and automated alerts to catch unusual behavior early.
• Have a plan in place before something goes wrong. HIPAA requires you to notify affected individuals and regulators quickly if a breach occurs.
• As your product evolves, so should your compliance strategy. Review policies, re-run risk assessments, and stay current with regulations at least once a year.