HIPAA / Healthtech Risk Register Template

Pre-populated risk register for healthtech companies with PHI-specific risks. Maps to HIPAA Security Rule. This free, professionally written template from Proveably is ready to download in multiple formats and customise for your organisation. No account required.

Identifies 15 HIPAA-specific risks including PHI exposure, BAA compliance, minimum necessary violations, and breach notification obligations.

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Why You Need This HIPAA / Healthtech Risk Register Template

A well-documented HIPAA / Healthtech Risk Register Template is essential for organisations pursuing compliance certifications and building trust with customers, partners, and auditors. Without formal documentation, your organisation faces several risks:

  • Audit failures — Auditors specifically check for documented policies. A missing or incomplete risk_register is one of the most common reasons organisations fail SOC 2, ISO 27001, or other compliance audits.
  • Security gaps — Without clear guidelines, employees and contractors may follow inconsistent security practices, creating vulnerabilities.
  • Regulatory exposure — Many regulations (GDPR, HIPAA, PCI DSS) require documented policies. Non-compliance can result in fines and legal liability.
  • Lost business opportunities — Enterprise customers increasingly require vendors to demonstrate formal security policies before signing contracts.

This Proveably template gives you a professional starting point that covers industry best practices and maps directly to compliance framework requirements.

Compliance Framework Requirements

This template is designed to satisfy requirements from the following frameworks:

hipaa

This template addresses key hipaa control requirements with pre-mapped sections and audit-ready language.

Specifically mapped control codes: §164.308, §164.310, §164.312

Template Preview

# HIPAA Healthtech Risk Register ## Risk Register | # | Risk | Category | Likelihood | Impact | Score | Level | HIPAA Reference | Existing Controls | Planned Controls | |---|---|---|---|---|---|---|---|---|---| | 1 | PHI exposed via application vulnerability | Security | 3 | 5 | 15 | High | §164.312(a) | Encryption, access controls | Penetration testing, WAF | | 2 | Unauthorized PHI access by employee | Access | 3 | 5 | 15 | High | §164.312(a) | Role-based access, audit logs | Automated access reviews, DLP | | 3 | PHI transmitted without encryption | Data | 2 | 5 | 10 | Medium | §164.312(e) | TLS enforcement | Certificate monitoring, HSTS | | 4 | Business Associate not BAA-compliant | Vendor | 3 | 4 | 12 | High | §164.314(a) | BAA tracking | Automated BAA monitoring | | 5 | Backup containing PHI not encrypted | Data | 2 | 5 | 10 | Medium | §164.312(a) | Encrypted backups | Backup encryption verification | | 6 | PHI in development/test environment | Data | 3 | 4 | 12 | High | §164.308(a)(4) | Environment separation | Data masking, synthetic data | | 7 | Workforce member not trained on HIPAA | People | 3 | 3 | 9 | Medium | §164.308(a)(5) | Annual training | Quarterly training, phishing sims | | 8 | Audit logs insufficient for investigation | Operations | 3 | 4 | 12 | High | §164.312(b) | Application logging | SIEM, 6-year retention | | 9 | Missing breach notification process | Compliance | 2 | 5 | 10 | Medium | §164.408 | Incident response plan | Automated breach assessment | | 10 | PHI retained beyond necessary period | Data | 3 | 3 | 9 | Medium | §164.530(j) | Retention policy | Automated data lifecycle management | | 11 | Mobile device with PHI access lost/stolen | Physical | 3 | 4 | 12 | High | §164.310(d) | MDM, encryption | Remote wipe, geofencing | | 12 | Minimum necessary principle violated | Access | 3 | 3 | 9 | Medium | §164.502(b) | Role-based access | Attribute-based access control | | 13 | Disaster recovery fails for PHI systems | Availability | 2 | 5 | 10 | Medium | §164.308(a)(7) | Database backups | DR testing quarterly | | 14 | Third-party API leaking PHI | Integration | 3 | 4 | 12 | High | §164.312(e) | API authentication | API DLP, logging | | 15 | Physical access to PHI systems not controlled | Physical | 2 | 4 | 8 | Medium | §164.310(a) | Office access controls | Visitor logs, camera monitoring | --- *Last Reviewed: [Date]* *Next Review: [Date + 90 days]*

Frequently Asked Questions

A HIPAA / Healthtech Risk Register Template is a formal risk register that pre-populated risk register for healthtech companies with phi-specific risks. maps to hipaa security rule. It provides a structured framework for organisations to document and enforce security and compliance requirements.
Yes. Proveably provides this HIPAA / Healthtech Risk Register Template template completely free of charge. You can download it in Markdown, PDF, Word, Excel, or plain text format — no account required.
This risk register is mapped to hipaa. It includes the specific control references and requirements needed to satisfy auditor expectations for these frameworks.
Download the template in your preferred format, then customise the bracketed placeholder sections with your organisation's specific details. Review with your security team or compliance officer, get management approval, and distribute to relevant staff. Proveably recommends reviewing and updating this risk register at least annually.
Absolutely. This template is designed as a starting point. All sections should be tailored to your organisation's size, industry, and specific compliance requirements. The placeholder text indicates sections that require customisation.

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