If your healthtech startup interacts with Protected Health Information (PHI), even indirectly, you’re not just building a product—you’re entering a highly regulated space. Under HIPAA, your company may be considered a Business Associate, and that title comes with serious responsibility: protecting PHI with the same diligence as hospitals and clinics.
A strong first move? Sign a Business Associate Agreement (BAA) with each provider you collaborate with. These aren’t just paperwork—they’re legally binding documents that define how PHI is handled, who’s accountable during a breach, and how compliance is enforced. Still unsure about where your startup stands? Checking out our HIPAA compliance checklist is a great place to start.
While HIPAA is about patient privacy, SOC2 is your ticket to proving operational integrity. With its focus on five Trust Services Criteria—security, availability, privacy, confidentiality, and processing integrity—SOC2 is especially critical for data-driven startups building in the cloud. Curious where you land? Here’s a SOC2 checklist to get you started.
Good compliance practices start early. Encrypt all PHI, limit access by role, and regularly review who’s inside your system. Be upfront with users about how their data is used, and always ask for consent—especially if you’re crossing borders where GDPR or other privacy laws apply.
Need a checklist for ongoing compliance? Try this:
• Run HIPAA and cybersecurity audits regularly.
• Implement multi-factor authentication and monitoring.
• Track state privacy laws and update policies accordingly.
• Build a compliance dashboard to manage audits, BAAs, and training.
• Consult the FDA if your tech might be a medical device.
Whether you're pre-seed or preparing for scale, treating compliance like a core product feature—not an afterthought—will save you time, money, and reputational risk down the road. It’s how startups grow into trusted partners in healthcare.
Compliance can feel overwhelming—but you don’t have to figure it out alone. Book a FREE CONSULTATION with Riskophia and let’s assess your needs, simplify your strategy, and set your startup up for long-term success. If you’re interested, let us know through here!
