Protect Patient Data. Enable Digital Health.

For most digital health startups, I can help you achieve HIPAA compliance in 3-6 months depending on your current maturity. Companies with existing security foundations may move faster, while those starting from scratch typically need the full timeline. The key is building a sustainable program, not just checking boxes.

HIPAA is a legal requirement—you must comply if you handle PHI. HITRUST CSF is a comprehensive certification framework that incorporates HIPAA requirements plus additional controls from ISO 27001, NIST 800-53, and other standards. Many large health systems and payers now require HITRUST certification from their vendors. I help you build one program that satisfies both, with HITRUST certification providing third-party validation of your HIPAA compliance.

If you have any EU patients, process data from EU clinical trials, or partner with EU healthcare organizations, GDPR applies to you regardless of where you're headquartered. GDPR has stricter requirements than HIPAA in several areas, including consent, data subject rights, and breach notification (72 hours vs 60 days). I help healthcare companies layer GDPR requirements onto their existing HIPAA programs.

The California Privacy Rights Act (CPRA) creates additional obligations for healthcare companies serving California residents. While HIPAA-covered data has some exemptions, many digital health companies have data that falls under CPRA but not HIPAA. I help you navigate the overlap and build compliant data handling practices for both frameworks.

AI in healthcare adds layers of complexity around data handling, model training, and algorithmic transparency. I help healthcare companies implement AI governance frameworks that address HIPAA requirements for PHI used in model training, FDA software documentation requirements, and emerging state-level AI regulations in healthcare.

HIPAA requires notification within 60 days; GDPR requires 72 hours; CPRA has its own timeline. Having an incident response plan that accounts for all applicable frameworks is critical. I help you build and test IR playbooks, establish relationships with forensics firms, and prepare breach notification templates for each jurisdiction so you're ready if something happens.