Healthcare compliance management software
We build healthcare compliance software that runs the program day to day: policy and attestation tracking, evidence collected directly from your EHR, identity provider and cloud, user access certification, audit log review, BAA and vendor registers, and incident and breach workflows with the regulatory deadlines built in. One control maps to HIPAA, HITRUST, SOC 2, ONC and CMS requirements, so your team collects evidence once.
Design your compliance softwareFor provider organizations, payers, health tech companies and compliance-product builders replacing spreadsheets or extending a GRC tool. Updated September 26, 2026.
HIPAA, Part 2, ONC, CMS or state requirement with an approved owner
One control mapped to every framework it satisfies
Pulled from the source system with date, version and reviewer
Gap, remediation, verification and a retained history
Illustrative workflow · scope tailored to your environment
The short answer
Healthcare compliance software is the system a provider, payer or health tech company uses to run its regulatory program. It records which obligations apply and who owns them, tracks policies and attestations, collects evidence from source systems, runs access reviews and risk assessments, manages incidents and breach notifications, and keeps an audit-ready history of every decision. Generic GRC tools cover common frameworks; healthcare needs evidence from clinical systems such as EHR audit logs and consent records, and workflows for rules like 42 CFR Part 2, information blocking and CMS-0057-F.
Read the HIPAA Security Rule 2026 checklistStart with the real problem
Most healthcare organizations have policies. What they lack is proof that the controls behind them ran: which terminated users were removed from the EHR and when, who reviewed last quarter's access, whether the encryption setting in the screenshot is still true, which vendor BAA expired, and how long the breach risk assessment took. When that proof lives in email and spreadsheets, every HIPAA review, HITRUST assessment or SOC 2 audit restarts from zero. We build software that pulls the evidence from the systems that produce it and records every review decision with its reviewer and date.
What we build
Each module can stand alone or run inside one platform. We scope them around the regulations you answer to.
Versioned policies and procedures, annual review cycles, workforce attestations and training records, with the history HIPAA expects you to keep for six years.
Healthcare compliance engineeringOne control library mapped to the HIPAA Security Rule, HITRUST CSF, SOC 2 Trust Services Criteria and NIST CSF, with evidence collected automatically where the source system allows it.
Privacy and security engineeringPeriodic user access reviews across the EHR, billing and cloud, plus review of EHR access logs for inappropriate record access, with reviewer sign-off.
HIPAA compliant software developmentSecurity incident intake, the four-factor breach risk assessment, notification decisions and the federal and state deadlines that follow.
Healthcare security architecture guideConsent capture and segmentation for substance use disorder records, and a log of every access, exchange or use request with the response or exception applied.
Patient identity and consentTracking and reporting for CMS-0057-F: prior authorization decision timeframes, public metrics reporting and API readiness evidence.
CMS-0057-F interoperability suiteYour starting point
Controls, owners, evidence and findings live in spreadsheets and shared drives. We move them into one system without losing history, then automate the evidence that can be automated.
You sell compliance or risk software to providers, payers or health tech companies. We build the multi-tenant platform, framework mappings and connectors your customers expect.
Your EHR, data platform or payer system must now handle Part 2 consent, information blocking requests or CMS-0057-F reporting. We build the workflows inside the product your users already run.
The Engineering Engagement
Workstreams are selected around your priorities. Each comes with an output your team can inspect, test and own.
Record each obligation with its source citation, applicability decision, owner and review cadence, and map it to controls that can satisfy several frameworks at once.
Pull configuration, identity, change and audit data from cloud accounts, identity providers, code repositories, device management and the EHR, with collection date and expiry on every item.
Run periodic reviews of who can access which system and role, route them to managers and system owners, and track every revocation to completion.
Support the HIPAA security risk analysis with an asset and data-flow inventory, threat and likelihood scoring, and remediation tasks verified before closure.
Handle security incidents, breach risk assessments and notification deadlines, and keep a register of business associates, BAAs, renewal dates and vendor risk reviews.
Produce assessor-ready evidence packages, overdue-review dashboards and board reports, stored in a tamper-evident log with retention rules set by your compliance lead.
Compare your options
Most organizations should not build a GRC tool from scratch. Build or extend when your evidence lives in clinical and payer systems a generic tool cannot reach.
| Custom or extended build | Off-the-shelf GRC platform | Spreadsheets and shared drives | |
|---|---|---|---|
| Best for | Healthcare-specific evidence, regulated workflows and compliance products | Common frameworks with standard cloud and identity evidence | Very small teams with a handful of controls |
| Evidence from EHR and payer systems | Connectors built for your EHR audit logs, consent records and claims data | Limited to the platform's connector catalog | Manual screenshots and exports |
| Healthcare rules (Part 2, information blocking, CMS-0057-F) | Modeled as workflows with deadlines and audit trails | Usually tracked as generic controls or tasks | Tracked by hand |
| Framework mapping | Your control library mapped to HIPAA, HITRUST, SOC 2 and NIST | Vendor-maintained framework content | Maintained by hand per framework |
| Audit trail of decisions | Every review, approval and exception recorded with reviewer and date | Platform audit log | Version history at best |
| Cost shape | Build cost, then run and improve | Annual subscription that grows with scope | Staff time that grows with every audit |
A common pattern: keep a GRC platform for the framework library and build the healthcare connectors and workflows that feed it.
Expertise is in the decisions
Administrative, physical and technical safeguards under 45 CFR 164.308 to 164.316, including information system activity review and audit controls. Breaches of unsecured PHI need notice to individuals without unreasonable delay and within 60 days of discovery; breaches affecting 500 or more people also need prompt notice to HHS, and to the media when 500 or more residents of a state are affected. HHS proposed a Security Rule update in January 2025 that would make most safeguards required, including encryption and multi-factor authentication.
Many health systems ask vendors for a HITRUST certification or a SOC 2 report. HITRUST certifies after an authorized external assessor validates the assessment, and a licensed CPA firm issues SOC 2 reports. Your software should map one control set to both, so evidence collected once serves each assessment.
The 21st Century Cures Act and 45 CFR Part 171 prohibit practices likely to interfere with access, exchange or use of electronic health information, unless an exception applies. Developers of certified health IT and health information networks and exchanges face civil money penalties of up to $1 million per violation, and providers face CMS disincentives. The ONC HTI rules also set certification and decision support transparency requirements.
Since 1 January 2026, impacted payers must decide expedited prior authorization requests within 72 hours and standard requests within 7 calendar days, and publish prior authorization metrics annually. The Patient Access, Provider Access, Payer-to-Payer and Prior Authorization APIs are due from 1 January 2027.
The 2024 final rule aligned substance use disorder record protections more closely with HIPAA, allowing a single consent for treatment, payment and health care operations, and adding breach notification and HIPAA-style penalties. Compliance was required from 16 February 2026, so consent and segmentation need to be tracked in software.
Washington's My Health My Data Act, California's CMIA and Texas HB 300 add consent, access and training duties beyond HIPAA. Health apps outside HIPAA fall under the FTC Health Breach Notification Rule. Your software should tag records and workflows by the laws that apply to them.
HIPAA has no government certification. A HITRUST certification comes from HITRUST after an external assessor validates the assessment, and a SOC 2 report comes from a licensed CPA firm. Our software produces and organizes the evidence those assessors test.
Your privacy officer, security officer and counsel decide which obligations apply. The software records who approved each decision and when, and flags it for review when the rule changes.
Timeline
The schedule depends on the number of frameworks, source systems to connect and whether you are building for your own program or for customers.
Map obligations, frameworks, owners, source systems and current evidence.
Controls, policies, attestations, findings and review workflows with roles and audit trail.
Cloud, identity, code, device and EHR connectors, added in order of audit value.
Incident and breach, access certification, Part 2, information blocking and CMS-0057-F modules as needed.
Delivered work
Client names are withheld; each is a real engagement. Our open-source work is public on GitHub.
Open-source Coverage Requirements Discovery, Documentation Templates and Rules, and Prior Authorization Support servers, tested with the Inferno test kits.
Every value on a case report form traces to a person, a time and a reason under a hash-chained audit trail that cannot be edited, with consent tracked and source data verification queues.
Recording is refused without consent on file, every clinician decision on an AI draft is audited, and prompts are versioned with a SHA-256 hash of each version written to the audit trail.
Audited and closed inherited security gaps in a live app that had passed through several vendors before any new feature shipped, then kept releasing to the app stores.
A FHIR R4 EHR with SMART App Launch that passed 47 of 47 ONC (g)(10) SMART App Launch tests in Inferno on 11 June 2026.
From discussion to delivery
Obligations, frameworks, owners, systems and current evidence, agreed with your compliance lead.
Control library, framework mappings and evidence lifecycle prototyped and reviewed.
Workflows, roles, audit trail and evidence connectors delivered in two-week increments.
Run a real access review or assessment through the system, then hand over or operate it.
We agree the scope, dependencies, acceptance criteria and commercial model before implementation. Your existing team can stay involved throughout.
Find the right starting point ↗Before you commit
It runs the compliance program as a system rather than a set of spreadsheets: it tracks obligations and owners, manages policies and attestations, collects evidence from source systems, runs access reviews and risk assessments, handles incidents and breach notifications, and keeps a dated history of every decision for auditors.
HIPAA Privacy, Security and Breach Notification Rules, 42 CFR Part 2, information blocking under 45 CFR Part 171, ONC certification requirements, CMS-0057-F for impacted payers, state laws such as Washington's My Health My Data Act, California's CMIA and Texas HB 300, and the FTC Health Breach Notification Rule. Frameworks such as HITRUST CSF, SOC 2 and NIST CSF map onto the same control library.
Yes, wherever the source system has an API or log. Typical collectors pull encryption and logging settings from AWS, Azure and Google Cloud, MFA and user lists from Okta or Microsoft Entra ID, change and review records from GitHub, device status from MDM, and access logs from the EHR. Each item carries its collection date and expiry, so stale evidence is flagged before an audit.
Yes. We map one control set to HITRUST CSF requirements and SOC 2 Trust Services Criteria, collect the evidence once and export it in the structure your assessor or CPA firm requests. The certification or report itself is issued by HITRUST or the CPA firm after their testing.
It pulls users and roles from the EHR, billing system, cloud and identity provider, sends review campaigns to managers and system owners, records each keep or revoke decision, and tracks revocations until the access is actually removed. This supports the HIPAA requirement to review information system activity and access.
Incidents are logged with facts, systems and data involved. The workflow guides the four-factor HIPAA breach risk assessment, records the decision, and starts the right clocks: no later than 60 days for individual notice, prompt HHS notice for breaches affecting 500 or more people, media notice when 500 or more residents of a state are affected, and any shorter state deadlines.
We tag substance use disorder records at the source, capture and store the patient's consent, apply segmentation when data is shared, attach the required redisclosure notice and log every disclosure. The 2024 final rule's compliance date of 16 February 2026 has passed, so these controls are now in force.
Yes. It logs each request for access, exchange or use of electronic health information, the response time, and any exception applied with the facts that support it. That record is what you need if a complaint reaches ONC or the HHS Office of Inspector General.
Yes. For impacted payers it tracks prior authorization decision times against the 72-hour expedited and 7-day standard limits, produces the annual public metrics report, and stores API test evidence for the Patient Access, Provider Access, Payer-to-Payer and Prior Authorization APIs.
Buy a GRC platform when your evidence is mostly cloud and identity configuration. Build or extend when evidence lives in clinical and payer systems, when you need Part 2, information blocking or CMS workflows, or when compliance software is the product you sell. Many teams connect custom healthcare connectors to an existing GRC platform.
Cost depends on the number of frameworks, the source systems to connect, the regulated workflows you need and whether the product is multi-tenant. We give a fixed-scope estimate after discovery, broken down by module and connector, so you can phase the build around your next audit.
Yes, we sign BAAs and we are ISO 27001:2022 certified. Compliance evidence often contains PHI and security details, so the software applies role-based access to viewing and export, encrypts evidence at rest and in transit, and logs every access.
A useful first conversation
Tell us what exists today, who uses it and where the workflow breaks. We’ll discuss the scope, access dependencies and the next practical step.
A product overview and a de-identified workflow are enough to start. No patient records or credentials are needed.
These are independent reference sources, not endorsements. Applicability, platform access and current requirements are confirmed for your project.
