HIPAA Policies for UK SaaS Serving US Healthcare
11 policies covering the HIPAA Security and Privacy Rules — written for UK SaaS firms operating as Business Associates to US covered entities. BAA-ready in 48 hours.
ISO 27001 Core Set pack
16 policies · £400 one-off
Pair with our HIPAA add-on for Business Associate readiness
What is HIPAA?
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?
- 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
The Security Rule's Administrative Safeguards require around 9 specific policies, plus the Privacy Rule adds several more. These 11 policies 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
Most UK SaaS firms reach Business Associate readiness in 6–10 weeks, with policies being the fastest part thanks to PolicySuite.
- Week 1: Scope PHI — which systems, which flows, which sub-processors. Buy the pack; receive bespoke policies in 48 hours.
- Week 2–3: Implement technical controls — MFA, encryption at rest/in transit, audit logging, session timeouts.
- Week 4–5: Run Security Risk Analysis (§164.308) and document findings.
- Week 6–7: Update BAAs with sub-processors, train workforce, run contingency drill.
- Week 8–10: Present evidence to US covered-entity clients, sign BAAs, go live.
Policy packs for HIPAA
ISO 27001 Core Set
16 policies · £400 · 80% of HIPAA Security Rule coverage
InfoSec 38 Enterprise Pack
38 policies · £900 · enterprise depth for BAAs
US Healthcare Compliance Essentials
11 policies · £500 · HIPAA Security + Privacy Rule
Incident Notification & Breach Reporting
8 policies · £250 · HITECH breach templates
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 11 policies 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 ISO 27001 Core Set.
What does the HIPAA policy pack include?
11 HIPAA-aligned policies: Administrative, Physical and Technical Safeguards, Breach Notification, Workforce Training, BAAs (with model template), Minimum Necessary, PHI Access, Risk Analysis, Contingency Plan, and Security Awareness. Built for UK SaaS firms serving US covered entities — see live pricing.
Be BAA-ready for your next US client
Get 16 bespoke security policies covering the HIPAA Security Rule — lifetime access.
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