Health Policy & Regulatory Consulting
Healthcare technology operates within a complex regulatory landscape. We help health tech companies understand and respond to federal rules, certification requirements, and industry standards that directly affect product development and market access.
Federal Regulations We Track
ONC Cures Act Final Rule
The 21st Century Cures Act has reshaped how health IT systems share data. We help companies understand information blocking provisions, Conditions and Maintenance of Certification requirements, and how these rules affect product roadmaps. We translate regulatory language into actionable engineering requirements.
CMS Interoperability Rules
CMS rules on patient access APIs, prior authorization, provider directories, and payer-to-payer data exchange create both requirements and opportunities for health tech companies. We help you understand which rules apply to your product and how to build compliant solutions.
USCDI & Data Standards
The United States Core Data for Interoperability (USCDI) defines the minimum data classes and elements that must be supported. We help companies map their data models to USCDI requirements, understand versioning implications (USCDI v1 through v4+), and prepare for expanded data class requirements.
CMS-0057-F & HL7 Da Vinci (ePrior Auth)
The CMS-0057-F final rule mandates electronic prior authorization APIs for payers, built on HL7 Da Vinci Implementation Guides. We help health tech companies and payers implement the Da Vinci Prior Authorization Support (PAS) IG, Documentation Templates and Rules (DTR), and Coverage Requirements Discovery (CRD) workflows. We translate CMS compliance deadlines into technical roadmaps and help teams build FHIR-based prior auth solutions that meet both the rule's requirements and real-world payer/provider workflows.
How We Help
Regulatory Impact Assessment
New rules get published regularly across ONC, CMS, and other agencies. We help your team assess which regulations affect your product, timeline implications, and what technical changes are needed. We turn Federal Register language into product requirements your engineering team can act on.
Compliance Strategy
Meeting regulatory requirements isn't just about checking boxes — it's about building compliance into your product and processes from the start. We help companies design architectures and workflows that satisfy current requirements while positioning for upcoming rule changes.
Industry Standards Guidance
Beyond federal rules, the healthcare industry has its own ecosystem of standards bodies and voluntary frameworks — HL7 International, CARIN Alliance, DaVinci Project, Argonaut Project, and SMART Health IT. We help companies understand which initiatives matter for their product and how to engage with the standards community.
Policy Monitoring & Updates
The regulatory landscape changes continuously. We track proposed rules, final rules, enforcement timelines, and industry comment periods. Our clients receive timely analysis of how regulatory changes affect their products and what actions to take.
Key Regulatory Areas
- Information blocking
- Patient Access API requirements and TEFCA IAS
- Prior authorization automation (CMS-0057)
- Trusted Exchange Framework (TEFCA)
- Provider directory requirements
- Payer-to-payer data exchange
- NCPDP and Electronic prescribing workflows
- Public health reporting processes and requirements