HIPAA Policies for UK SaaS Serving US Healthcare
Prepare editable policy drafts from your business answers after checkout. Review their scope and approve drafts before use.
US Healthcare Compliance Essentials pack
10 policies · £300 one-off
Review the included policy scope before purchase
After checkout, answer questions about your business. Confirm your answers before generating policy drafts, then review and edit those drafts before use. The listed jurisdictions define this product’s coverage.
Free account · preview sample policies · buy pack when readyWhat is HIPAA?
Quick answer. HIPAA (Health Insurance Portability and Accountability Act 1996) is the US federal law governing protected health information (PHI). The Privacy Rule covers use and disclosure; the Security Rule covers safeguards for electronic PHI; the Breach Notification Rule sets timelines and disclosure thresholds. Enforced by the US Department of Health and Human Services Office for Civil Rights (HHS OCR), with tiered civil penalties up to ~$2.1M per violation category per year (2024-adjusted).
The Health Insurance Portability and Accountability Act is a US federal law regulating Protected Health Information (PHI). It applies to Covered Entities (US healthcare providers, health plans, clearinghouses) and to their Business Associates — any vendor processing PHI on their behalf. UK SaaS firms operating in that chain are directly liable for HIPAA compliance.
HIPAA's two key rules are the Security Rule (technical, administrative and physical safeguards for electronic PHI) and the Privacy Rule (how PHI can be used and disclosed, patient rights). The HITECH Act layered on breach-notification obligations and stricter enforcement. HHS Office for Civil Rights (OCR) enforces it, including against non-US Business Associates.
Who needs HIPAA policies?
Quick answer. US-headquartered covered entities (health plans, providers, clearinghouses) and business associates. For UK firms, the question is whether you act as a business associate to a US covered entity — common for UK SaaS providers selling into US healthcare, BPOs handling PHI on behalf of US payers, and clinical-trial subcontractors. If you handle PHI under a Business Associate Agreement, HIPAA applies regardless of geography.
- UK SaaS firms with US healthcare clients — EHR vendors, telehealth platforms, patient-engagement tools, analytics providers.
- UK BPO and support providers handling PHI on behalf of US hospitals or clinics.
- UK AI and ML firms training on US health data — double scrutiny on de-identification and safeguards.
- UK cloud and hosting providers used by US covered entities — typically BAA signatories.
- UK medical devices and digital health startups selling into the US market.
Policies you need for HIPAA
Quick answer. HHS OCR audits test 11 policy areas: privacy practices notice, minimum necessary, uses and disclosures, individual rights (access, amendment, accounting), business associate management, breach notification, administrative safeguards, physical safeguards, technical safeguards (access controls, audit logs, encryption), workforce training and contingency plan. PolicySuite’s US Healthcare pack covers all 11 with HIPAA-specific language.
The Security Rule's Administrative Safeguards require around 9 specific policies, plus the Privacy Rule adds several more. These 10 policy drafts are the typical Business Associate scope for a UK SaaS firm:
Administrative Safeguards
§164.308 — security management, workforce, training, sanctions.
Physical Safeguards
§164.310 — facility access, workstation use, device controls.
Technical Safeguards
§164.312 — access control, audit, integrity, transmission security.
Breach Notification
HITECH §164.404–414 — 60-day notification, OCR reporting.
Workforce Training
Role-based HIPAA training on hire and annually.
Business Associate Agreements
BAA template + process for signing with covered entities and sub-BAs.
Minimum Necessary Standard
Privacy Rule §164.502 — role-based PHI access limits.
PHI Access
Patient rights: access, amendment, accounting of disclosures.
Risk Analysis
§164.308(a)(1)(ii)(A) — ongoing risk analysis of ePHI systems.
Contingency Plan
§164.308(a)(7) — DR, emergency mode, data backup plan.
Security Awareness
§164.308(a)(5) — security reminders, malware, logins, passwords.
Realistic timeline for UK firms
Planning your rollout. There is no fixed readiness timetable. After purchase, complete the business questions and confirm your answers to generate editable drafts. Review, approve and implement them before use. Evidence collection and any independent assessment take additional time.
Policy packs for HIPAA
US Healthcare Compliance Essentials
10 policies · £300 · healthcare policy drafting foundation
InfoSec 38 Enterprise Pack
39 policies · £950 · enterprise depth for BAAs
US Healthcare Compliance Essentials
10 policies · £300 · HIPAA Security + Privacy Rule
Incident Notification & Breach Reporting
21 policies · £500 · HITECH breach templates
PolicySuite vs GRC platforms vs consultant vs DIY
Compare the scope. PolicySuite prepares editable policy drafts from your business answers. Compare the included documents and current shop price with the scope offered by a consultant, a template supplier or a governance platform. Implementation, specialist advice and independent assessment may require separate work.
Further reading
Frequently asked questions
Does HIPAA apply to UK companies?
HIPAA is US federal law, but UK SaaS firms processing PHI on behalf of US covered entities qualify as Business Associates and are directly liable. You'll need a BAA with each US healthcare client and must demonstrate Security Rule compliance to them and — if audited — to the US HHS Office for Civil Rights.
What is a Business Associate Agreement?
A BAA is a required written contract between a covered entity and any vendor handling PHI on its behalf. It defines obligations around use, disclosure, safeguards, breach notification, and sub-contractor management. No BAA = no permitted processing of PHI. Our pack includes a model BAA template plus the policies that make it enforceable.
What policies does HIPAA require?
The Security Rule requires documented Administrative, Physical and Technical Safeguards. The Privacy Rule adds use/disclosure, minimum-necessary, patient rights and breach notification. Business Associates typically need 10 policy drafts covering all those areas — all included in our pack.
How do HIPAA fines work?
HHS Office for Civil Rights can impose civil penalties from $100 to $71,162 per violation, capped at $2.1 million per year per violation type (2024 figures). Criminal penalties for wilful disclosure go up to $250,000 and 10 years. OCR actively pursues cross-border Business Associates after breach events.
Does ISO 27001 get me HIPAA compliance?
ISO 27001 covers about 80% of HIPAA Security Rule requirements but misses HIPAA-specific concepts — workforce sanctions, minimum-necessary, BAAs, the entire Privacy Rule. Most UK SaaS firms serving US healthcare run ISO 27001 as backbone plus a HIPAA-specific overlay. Our pack is designed to sit on top of US Healthcare Compliance Essentials.
What does the HIPAA policy pack include?
The US Healthcare Compliance Essentials pack contains 10 policy drafts. Check the included documents and scope in the shop before buying; the pack does not establish complete HIPAA compliance. Built for UK SaaS firms serving US covered entities — see live pricing.
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Get Started — £300References and primary sources
Quick answer. The framework guidance on this page is reviewed against the primary-source documents below. Each link resolves to an official regulator or standards-body publication so an auditor, procurement reviewer or DPO can verify the alignment without taking the page on trust.
- HHS Office for Civil Rights — the US federal regulator with HIPAA enforcement authority.
- NIST SP 800-66 (HIPAA security) — NIST’s HIPAA security rule implementation guide.
- CISA Healthcare guidance — sector-specific cybersecurity advisories for HIPAA-covered entities.
- ISO 27001 alignment — the international standard many US healthcare SaaS use as the HIPAA baseline.
In our experience working with UK SMEs and similar organisations across the EU and US, the framework pages that survive enterprise vendor reviews are the ones that cite primary sources rather than secondary blog posts. Many UK SMEs typically discover this only after their first failed vendor questionnaire — the reviewer asked for a clause-to-source map and the standard reply pointed at a marketing page rather than the relevant regulator. The references above are the standing set we cite from inside the policies themselves so the chain stays intact end-to-end.