Kara Sears
While the UK does not have a law equivalent to HIPAA, UK businesses that process US healthcare data or have US health consumers are required to comply with HIPAA. This is because HIPAA, or the Health Insurance Portability and Accountability Act, is a US law that protects the privacy and security of Protected Health Information (PHI). This includes an individual's medication and diagnosis history, laboratory test results, and insurance information. In the UK, the National Health Service (NHS) regulates how organisations handle PHI and digital health products.
| Characteristics | Values |
|---|---|
| Is there a HIPAA law in the UK? | No, HIPAA is an American law. |
| Does HIPAA apply to UK businesses? | Yes, if they provide services to US healthcare customers or handle US patient data. |
| What is the UK equivalent of HIPAA? | The General Data Protection Regulation (GDPR) or the Data Protection Act 2018. |
| What does HIPAA protect? | Protected Health Information (PHI), including an individual's medication, diagnosis history, laboratory test results, and insurance information. |
| What are the benefits of adopting HIPAA standards in the UK? | Improved cybersecurity, quicker access to the US healthcare market, and enhanced data protection. |
| What are the consequences of non-compliance in the UK? | Financial damage, legal damages, and a breakdown of trust with patients. |
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What You'll Learn
UK businesses that process US healthcare data
In the UK, the National Health Service (NHS) regulates how organisations handle Protected Health Information (PHI) and digital health products. Before entering the UK market, all healthcare software solutions must comply with the NHS's requirements and ensure a proper level of health data privacy.
The UK does not have an equivalent to the US's Health Insurance Portability and Accountability Act (HIPAA). With universal coverage through the NHS, the UK did not face the same issues as the US. Instead, the UK has the Data Protection Act 2018, which is enshrined in UK law and covers all data protection.
The NHS is part of a wider ecosystem that includes private sector organisations that develop and run technology, research and produce vaccines and treatments, and provide and run healthcare services. Private sector organisations are involved in delivering care and research across the NHS, but strict controls are in place to protect patient privacy. Most of the time, these organisations can only access anonymised or pseudonymised data to help deliver an NHS service or undertake approved research projects.
The NHS has been criticised for selling patient data from GP surgeries to US companies. In 2019, it was revealed that US pharmaceutical companies had paid the Department of Health and Social Care for licences to access anonymised data for research purposes. Labour leader Jeremy Corbyn accused the Conservatives of preparing to open up the NHS to US businesses during talks on a post-Brexit trade deal. Boris Johnson denied these claims.
In 2023, NHS England awarded a £330 million contract to US spy tech firm Palantir and four partners to set up and operate the "federated data platform" (FDP). This platform will allow individual health service trusts and integrated care systems to share data and improve care and efficiency. However, there have been concerns about Palantir's involvement in "serious human rights abuses" and its ability to handle patients' data. NHS England has stressed that it will retain control of all data within the platform and that it will be protected by the highest security standards.
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The National Health Service (NHS) regulates how organisations handle PHI
In the United Kingdom, the National Health Service (NHS) regulates how organisations handle Protected Health Information (PHI) and digital health products. The NHS is a publicly funded healthcare system that provides universal coverage to all citizens. As such, the UK does not have an equivalent to the US Health Insurance Portability and Accountability Act (HIPAA).
The HIPAA Privacy Rule is a federal regulation that establishes national standards for the protection of individuals' medical records and other personal health information. It applies to healthcare providers, health plans, and healthcare clearinghouses, collectively referred to as covered entities, and governs how they manage PHI. The Privacy Rule protects all "individually identifiable health information" held or transmitted by a covered entity or its business associate, in any form or media, including electronic, paper, or oral. This includes demographic data, information about an individual's past, present, or future physical or mental health, the provision of healthcare to the individual, and the payment for said healthcare.
The HIPAA Security Rule complements the privacy standards established under HIPAA by requiring covered entities to implement administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and availability of electronic PHI (ePHI). The Security Rule protects a subset of individually identifiable health information, referred to as ePHI, which is PHI that is maintained or transmitted electronically. It is important to note that the Security Rule does not apply to PHI transmitted or maintained on paper or verbally.
The Administrative Simplification provisions of HIPAA require the Secretary of the Department of Health and Human Services (HHS) to adopt standards to ensure that covered entities maintain appropriate safeguards for the security of individually identifiable health information. HHS is responsible for administering and enforcing these standards and may conduct complaint investigations and compliance reviews.
In the UK, the Information Commissioner is responsible for enforcing data privacy laws and can impose fines of up to £17 million or 4% of global turnover for the most serious data breaches. While the UK does not have a specific law like HIPAA, it does have comprehensive data protection laws, such as the General Data Protection Regulation (GDPR) and the Data Protection Act 2018, which apply to all sectors, including healthcare.
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UK organisations handling US patient data must comply with HIPAA
In the US, all medical facilities, doctors, nurses, and other "covered entities", as well as everyone who works directly or indirectly with those entities ("business associates"), have to comply with the Health Insurance Portability and Accountability Act (HIPAA) Security Rule for handling protected health information (PHI). The purpose of the Security Rule is to avoid breaches of patient data, and non-compliance can result in stiff fines and harm to a company's reputation.
HIPAA is an American regulation, and it does not automatically apply in the UK. However, UK organisations providing services to US healthcare customers or handling US patient data are required to comply with HIPAA. This includes telemedicine providers treating US patients. Non-compliance in this context may result in legal penalties, contractual fines, or reputational harm.
UK medtech companies entering the US market must navigate a complex regulatory landscape, with HIPAA compliance being chief among them. While the GDPR (General Data Protection Regulation) is well understood in Europe, HIPAA presents a distinct and critical framework for protecting patient data in the United States. With over 85 million individuals affected by data breaches in 2024 alone, and a 102% increase in large-scale breaches since 2018, the urgency for robust data protection in the US has never been greater.
In the UK, the National Health Service (NHS) regulates how organisations handle PHI and digital health products. Before launching in the UK market, all healthcare software solutions must comply with certain requirements to ensure a proper level of health data privacy. If an organisation breaks the law and causes a data breach, the Information Commissioner can impose fines of up to £17 million (~US$24 million) or four per cent of global turnover for the most serious data breaches.
While GDPR and HIPAA both aim to protect personal data, they differ in scope. GDPR applies broadly to all personal data processing in the EU, while HIPAA is narrowly focused on patient health information within the US healthcare system. HIPAA's three core rules – the Privacy Rule, Security Rule, and Breach Notification Rule – form the backbone of compliance. The Privacy Rule governs how PHI is used and disclosed; the Security Rule mandates administrative, physical, and technical safeguards for electronic PHI (ePHI); and the Breach Notification Rule requires timely disclosure of data breaches to affected individuals and regulators.
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The benefits of adopting HIPAA standards for UK businesses
While the UK has no direct equivalent to the US Health Insurance Portability and Accountability Act (HIPAA), UK organisations providing services to US healthcare customers or handling US patient data are required to comply with HIPAA. This is because HIPAA is narrower and stricter in how medical information must be processed compared to the UK's GDPR, which deals with all data protection.
UK businesses that adopt HIPAA standards can gain quicker access to the US healthcare market. By being HIPAA-compliant, UK businesses can:
- Indicate to US partners and regulators that they meet the toughest data protection requirements.
- Strengthen their cybersecurity defences, particularly for healthcare data protection and privacy.
- Establish administrative, physical, and technical safeguards such as encryption, firewalls, and secure entry access.
- Implement an incident response plan to address security compromises.
- Draft business associate agreements with partners to guarantee accurate and uniform application of HIPAA standards.
HIPAA compliance can also make UK businesses safer, more reliable, and more competitive internationally.
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The differences between HIPAA and GDPR
The Health Insurance Portability and Accountability Act (HIPAA) is a US law that focuses on healthcare organisations and how personal health information is used. It only applies to HIPAA-protected health information (PHI), which includes any information that can be used to identify a patient, such as their name, address, date of birth, bank/credit card details, social security number, photos, and insurance information. It also covers business associates of covered entities, such as shredding companies, IT companies, or transcription services.
On the other hand, the General Data Protection Regulation (GDPR) is an EU regulation that came into force on 25 May 2018. It applies to all organisations dealing with the personal data of EU or UK citizens, regardless of whether the organisation is physically located within those jurisdictions. The GDPR sets standards for all sensitive personal data, including name, emails, physical address, IP address, health information, income, race, religion, political affiliations, sexual preferences, biometric or genetic data.
While both HIPAA and GDPR aim to protect the privacy of individuals, there are some key differences. Firstly, the scope of each framework differs, with HIPAA focusing specifically on healthcare organisations and PHI, while the GDPR has a broader scope and covers any organisation handling personally identifiable information. Secondly, the GDPR requires consent to be obtained for any processing of personal data, while HIPAA permits some degree of PHI disclosure without patient consent, such as for treatment purposes or to other healthcare providers or business associates. Thirdly, the GDPR has stricter breach reporting requirements, with a 72-hour deadline for reporting all breaches, regardless of their size.
Despite these differences, there is some overlap between the two frameworks. Both require organisations to have technical safeguards in place to protect data, control access to sensitive data, detect unauthorised changes to data, and encrypt data at rest and in transit. Organisations that are compliant with one framework may already have some of the necessary safeguards in place to comply with the other.
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Frequently asked questions
No, the UK does not have a law equivalent to HIPAA. The National Health Service (NHS) regulates how organisations handle Protected Health Information (PHI) and digital health products in the UK.
HIPAA stands for the Health Insurance Portability and Accountability Act, which was introduced in 1996 in the United States.
While HIPAA is primarily a US regulation, it can apply to international companies that manage US citizens' PHI. UK organisations providing services to US healthcare customers or handling US patient data are required to comply with HIPAA.
PHI, or Protected Health Information, includes an individual's medication and diagnosis history, laboratory test results, insurance information, treatment information, prescription information, identification numbers, and demographic information.
While there is no direct equivalent, the UK has the General Data Protection Regulation (GDPR), which is enshrined in UK law as the Data Protection Act 2018. GDPR deals with data protection for all organisations handling the personal data of EU or UK citizens.
