Health and life sciences organizations operate in the most compliance-intensive sector in the private economy. In healthcare, compliance maturity is the difference between closing a deal and losing it to a competitor with a better trust story. Agency's U.S.-based forward-deployed engineers and proprietary AI run your full program — HIPAA, HITRUST r2, SOC 2, GDPR — on top of the tools you already trust, building the trust story that wins deals, without hiring a compliance team.

Automation ends where judgment begins.

Offerings · Health & Life Sciences

Regulatory Landscape

Six frameworks that apply

HIPAA

PCI DSSAny organization that creates, receives, maintains, or transmits protected health information must comply with HIPAA's Security Rule, Privacy Rule, and Breach Notification Rule. Violations carry civil penalties up to $2.1 million per violation category per year.

HITRUSTThe premier compliance certification in healthcare. Hospitals, health plans, and enterprise healthcare buyers increasingly require HITRUST r2 certification from their technology partners and business associates. HITRUST harmonizes 40+ frameworks into a single maturity-based assessment.

SOC 2Healthtech companies pursuing SOC 2 alongside HIPAA cover both operational security and regulatory compliance, satisfying enterprise buyer procurement requirements.

ISO 27001Healthtech and biotech companies operating across borders use ISO 27001 alongside HIPAA and GDPR to cover the full spectrum of international regulatory obligations.

GDPRHealthtech companies processing EU patient data face GDPR's special category data protections in addition to HIPAA, creating compound compliance obligations.

ISO 42001AI-powered diagnostic tools, drug discovery platforms, and clinical decision support systems face increasing requirements around AI governance and responsible AI certification.

How Agency Operates Health & Life Sciences Compliance

Agency embeds U.S.-based forward-deployed engineers, supercharged by proprietary AI, directly into your security and compliance infrastructure, operating your entire compliance program across HIPAA, HITRUST, SOC 2, ISO 27001, and GDPR — because HITRUST maturity and PHI safeguards demand judgment automation alone can't deliver: automation ends where judgment begins — so your team builds healthcare technology while Agency builds the compliance maturity that enterprise buyers demand.

Multi-Framework Orchestration — Agency AI maps controls across HIPAA, HITRUST, SOC 2, ISO 27001, and GDPR in a unified ontology. Implement a control once and satisfy every overlapping requirement automatically. Agency AI orchestrates enforcement across your entire technology stack.

HITRUST Maturity Management — Agency implements and enforces HITRUST controls at the maturity level required for r2 certification. Every control is documented across all five maturity levels: policy, procedure, implementation, measurement, and management.

PHI Protection and Access Governance — Agency enforces HIPAA's administrative, physical, and technical safeguards continuously. CustodyID governs workforce access to PHI across identity providers, EHR systems, and cloud environments with minimum necessary enforcement and automated access reviews.

Comprehensive Evidence Management — With HITRUST's 2,000+ requirement statements, HIPAA's safeguard documentation, and SOC 2's observation period evidence, manual management is impossible. Agency collects, organizes, and maintains evidence for every requirement automatically.

Business Associate Management — Agency assesses and monitors every business associate continuously, ensuring BAAs are in place, vendor security posture meets HIPAA and HITRUST requirements, and vendor risk findings are documented and remediated.

Assessment Readiness — Agency prepares your organization for HITRUST r2 validated assessment, SOC 2 Type II audit, and ISO 27001 certification with validated controls, complete evidence packages, and real-time monitoring through Agency AI.

Managed Detection and Response — Agency MDR provides fully managed detection, response, and incident documentation with breach notification documentation meeting HIPAA's 60-day and GDPR's 72-hour notification requirements.

Critical Challenges

Nine places Health & Life Sciences compliance stalls

Cross-Framework Complexity Pursuing HIPAA, HITRUST, SOC 2, ISO 27001, and GDPR simultaneously creates an enormous overlap of controls. HITRUST alone harmonizes 40+ frameworks, but organizations already pursuing other certifications independently must map existing controls into HITRUST's maturity model.

Audited Compliance HIPAA requires documented administrative, physical, and technical safeguards. HITRUST evaluates maturity across five levels with up to 2,000+ requirement statements. SOC 2 demands continuous evidence over observation periods. Combined, the manual burden is staggering.

Vendor Risk Every business associate handling PHI must be governed by a BAA and demonstrate HIPAA-compliant security practices. HITRUST requires rigorous third-party risk management. The vendor risk surface in healthcare is enormous and carries direct liability.

Trust & Transparency HITRUST r2 certification is the strongest trust signal in healthcare. Organizations with HITRUST certification close deals faster, face fewer security objections, and reduce questionnaire volume dramatically.

Questionnaire Fatigue Healthcare enterprise buyers issue exhaustive security questionnaires. HITRUST certification can reduce questionnaire volume significantly, but until certification is achieved, every questionnaire consumes compliance team bandwidth.

Policy & Access HIPAA requires role-based access controls, workforce training, and minimum necessary access to PHI. HITRUST auditors evaluate policy maturity across five assessment levels.

BYOD Security Mobile devices accessing PHI must be encrypted, remotely wipeable, and governed by documented policies. BYOD in healthcare settings is pervasive and creates persistent compliance exposure.

Insider Risks Healthcare organizations face significant insider threat risk. Workforce members with access to PHI must be monitored, trained, and subject to sanctions for unauthorized access.

Agency for Health & Life Sciences

Your team builds healthcare technology. Agency builds the compliance maturity enterprise buyers demand.

Agency's U.S.-based forward-deployed engineers and proprietary AI run your full program — HIPAA, HITRUST r2, SOC 2, GDPR — on top of the tools you already trust, building the trust story that wins deals, without hiring a compliance team.

Work done for HIPAA carries forward to HITRUST, SOC 2, ISO 27001, and GDPR — implement a control once and satisfy every overlapping requirement automatically.

Platform Products

Agency AIEnd-to-end cybersecurity and compliance, across the stack you already use.

GRC IntegrationsEngineer-operated GRC platform integration

Agency MDRManaged detection and response

Find your auditor

Auditnex makes buying audits simpler and more transparent.

Agency implements the controls, collects the evidence, and manages your auditor relationship on top of the GRC tools you already use.

Explore Auditnex

Common GRC Questions

GRC Platform & Virtual CISO FAQ

Answers to common Health & Life Sciences compliance questions — which frameworks apply, how controls cross-map, and what a virtual CISO actually does for your program.

Read the FAQ

Explore offerings

Build a Security & Compliance Team Led by Your Own Virtual CISO

Forward-Deployed Engineers + AI that lower costs, increase velocity, and raise the bar — from policy to audit to remediation. U.S.-based forward-deployed engineers, supercharged by proprietary AI, operate your program end-to-end — on top of the tools you already trust.

Find Your SolutionAutomation ends where judgment begins.