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Entering the UK health market

Browne Jacobson is one of the UK's leading health and care law firms, with a dedicated team of specialist lawyers who advise NHS bodies, independent healthcare providers, digital health businesses, and international organisations entering the UK market. We have developed a structured legal services offering designed to provide end-to-end legal support across every stage of your establishment journey. Whether you require support across all workstreams or wish to select specific areas of advice, our team can work with you as a trusted legal partner throughout.

Our offering spans fourteen workstreams, from corporate set-up and Care Quality Commission (CQC) registration through to NHS contracting, data protection, MHRA regulation and real estate, on a pick-and-mix or full-suite basis, with fixed fees and full cost transparency from day one.

The UK’s health and care sector represents one of the most complex regulatory environments in the world, but with attractive investment opportunities. Alongside a highly developed independent healthcare market, the NHS – the world's largest publicly funded health system – operates under a distinct and intricate legal and contractual framework that demands specialist knowledge and practical experience to navigate successfully.

For international healthcare providers and investors seeking to establish a presence in the UK, the journey from initial incorporation to operational delivery involves navigating a web of overlapping legal, regulatory, and governance obligations. From CQC registration and clinical governance requirements to data protection, employment law, and NHS contracting frameworks (if relevant), each element carries material legal risk if not addressed properly from the outset.

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How we can support

Our specialist health team advises across the full spectrum of the UK health market, acting for NHS bodies, independent healthcare providers, digital health and life sciences businesses, and international market entrants. The team's key services include:

  • Corporate set-up and structuring. 
  • CQC registration and clinical governance. 
  • Health regulatory compliance (non-CQC).
  • Commercial contracts.
  • Governance frameworks. 
  • Data protection and information governance. 
  • MHRA regulation. 
  • Employment and immigration law. 
  • Professional liability and insurance signposting. 
  • Healthcare marketing, advertising and patient-facing communications.
  • Intellectual property. 
  • NHS contracting. 
  • Premises and real estate. 
  • Tax and VAT signposting. 

See our offering in detail

Why choose us?

  • Specialist health team: One of the UK's leading health and life sciences legal practices, advising NHS bodies, independent providers, and international market entrants.
  • Integrated delivery: A single team across all workstreams – no handoffs, no duplication, no gaps.
  • Regulatory depth: Direct experience of CQC, NHS contracting, MHRA, and UK GDPR in a health context.
  • Commercial pragmatism: Fixed and capped fees wherever possible, with full cost transparency from day one.

Our UK health market entry offering

Incorporation of a new UK limited company at Companies House, or advice on whether you can start up using an already established non-UK entity.

We can project manage the incorporation, draft bespoke articles of association, advise on the optimal corporate structure, and assist with any associated shareholders' or investment documentation if required. Key considerations include whether to incorporate in the UK, the appropriate corporate structure (e.g. wholly owned subsidiary or standalone vehicle), the composition of the board of directors, and the drafting of bespoke articles of association tailored to your operational requirements.

Corporate set-up

As you will be delivering regulated activities, registration with the CQC is a legal requirement under the Health and Social Care Act 2008 before operations can commence.

We can advise on CQC registration requirements, assist in preparing the application and supporting documentation, advise on the appointment of a Registered Manager, and help ensure that your clinical governance framework meets the Fundamental Standards.

CQC registration

We'll advise on all regulatory matters relevant to establishment of your business and advise on the legal elements of the health policies that are required for the business.

Browne Jacobson can conduct a structured legal review of each policy, examining them against the applicable regulatory, statutory, and common law frameworks in England. This will include assessing compliance with CQC fundamental standards and registration requirements, NHS commissioning frameworks (including NHS England's Mental Health Implementation Plan), the Health and Social Care Act 2012 (as amended), the Mental Health Act 1983 (as amended by the Mental Health Act 2007), and any relevant NICE guidelines with legal or regulatory implications. A written legal opinion or review note will be produced for each policy, clearly flagging areas of legal risk, non-compliance, or ambiguity, together with recommended amendments.

As well as advice in relation to CQC, we'll support on all requirements under the Health and Care Act 2022, and NHS provider licence conditions if NHS-funded services are intended.

Health regulatory (non-CQC) and health policies

Any international healthcare provider establishing operations in the UK will require a bespoke suite of commercial contracts and terms governing its relationships with patients, referral partners, technology providers, clinical staff, and other third parties.

These documents are the legal architecture that underpins your entire operation, allocates risk, protects revenue, and ensures regulatory compliance. The contracts required will depend on your business model, but the suite will typically span: patient-facing documents, referral partner and intermediary arrangements, clinical and professional services agreements, technology and digital health contracts, supplier and third-party contracts, and corporate and investor documents.

Browne Jacobson can provide support across the full commercial contracts suite, including drafting from our precedent bank, adapting your existing documents, legal review and risk flagging, and negotiation support.

We'll advise on your governance framework for the business and ensure all legal requirements are met.

We'll work collaboratively with you to develop a robust governance framework. Browne Jacobson will review and, where necessary, draft or redraft to ensure the governance framework meets legal requirements, including the duty of candour, safe staffing obligations, safeguarding requirements, and directors' duties under the Companies Act 2006. A joint governance manual will be produced as a key deliverable.

Data protection compliance is a fundamental legal obligation for any healthcare provider operating in the UK. Given the sensitivity of patient health data, the regulatory framework is both demanding and fast-evolving.

Establishing robust data protection and information governance arrangements from the outset is therefore essential, particularly with a possible cross-border element depending on proposed operations. This includes:

  • Compliance with the UK GDPR and the Data Protection Act 2018.
  • Ensuring that cross-border transfers are governed by appropriate transfer mechanisms.
  • Reviewing Data Processing Agreements (DPAs) with referral partners, technology providers, and other data processors.
  • Advising on patient-facing privacy notices.
  • Advising on the Data (Use and Access) Act 2025 and its implications for digital health data sharing.
  • Advising on NHS Data Security and Protection (DSP) Toolkit requirements, relevant if you contract with the NHS.
  • ISO 27001 certification as a recommended best-practice information security framework, particularly where working with the NHS.

Understanding whether any element of your product or service offering falls within the scope of MHRA regulation is an essential early step.

This includes digital health tools, software platforms, or AI-driven functionality. The regulatory position isn't always straightforward, and the consequences of failing to register a regulated product, or of marketing a product with an incorrect classification, can be significant — including enforcement action, reputational risk, and potential liability.

We can advise on the current regulatory position and the circumstances in which MHRA registration would be triggered.

MHRA regulation

You will need to engage clinical and non-clinical staff in the UK. Employment contracts and relevant employment policies and procedures must be considered.

Clinical policies and procedures will be required for medical staff. Where you're engaging any overseas employees, immigration advice will be required to ensure they have the necessary permissions to work in the UK.

We can prepare employment contracts for clinical and non-clinical staff, and assist with preparing an employee handbook to include necessary policies and procedures (disciplinary, grievance, absence management, whistleblowing, family leave). We can provide specialist immigration advice as required.

Healthcare providers must comply with specific rules governing the advertising and promotion of health services in the UK.

This includes the Advertising Standards Authority (ASA) CAP and BCAP Codes, GMC, NMC, and other professional body guidance on advertising, and specific restrictions on claims made in relation to clinical outcomes or treatments. Patient-facing materials beyond privacy notices also require legal review.

We can review your marketing materials, website content, and patient communications to ensure compliance with ASA requirements and applicable professional standards, and advise on permissible claims in relation to your clinical services.

Professional liability and insurance

You will wish to protect your brand and proprietary technology in the UK. We can advise on this and also recommend patent attorneys as required.

If you're planning to partner or contract with the NHS, you will need advice on partnering and contracting arrangements, any necessary frameworks that you could utilise, contracting with ICBs and NHS Trusts, and access to the NHS patient choice framework.

Also, we can provide advice in relation to the NHS standard contracts, the potential risks and mitigations, and how you may wish to mark those up (where possible). It is more than likely that your NHS contracting partners would expect to use the NHS standard suite of contracts to engage your services.

We can advise on the NHS landscape and system, the expectations in relation to contracting, likely contracting partners, and the NHS patient choice framework. The system can be difficult to navigate but we'll guide and support you. We'll also support you to negotiate and finalise your contracts with NHS parties, and know the suite of NHS standard contracts well.

NHS contracting

Most health providers will need to lease or acquire clinical or office premises in the UK. Healthcare premises are subject to specific planning use classes (Class E for health) and may require change of use consent.

Lease terms, break clauses, and service charges all require careful review. Your facilities will also need to be detailed in your CQC registration, so it's important to have these details early on.

Browne Jacobson can advise on the acquisition or leasing of UK premises, including healthcare-specific planning considerations, negotiation of heads of terms, and review and negotiation of commercial leases.

Establishing a UK subsidiary will give rise to UK tax considerations, including corporation tax registration, VAT registration (if required), and PAYE and National Insurance obligations for UK employees.

Incorporation of a new UK limited company at Companies House, or advice on whether you can start up using an already established non-UK entity.

We can project manage the incorporation, draft bespoke articles of association, advise on the optimal corporate structure, and assist with any associated shareholders' or investment documentation if required. Key considerations include whether to incorporate in the UK, the appropriate corporate structure (e.g. wholly owned subsidiary or standalone vehicle), the composition of the board of directors, and the drafting of bespoke articles of association tailored to your operational requirements.

As you will be delivering regulated activities, registration with the CQC is a legal requirement under the Health and Social Care Act 2008 before operations can commence.

We can advise on CQC registration requirements, assist in preparing the application and supporting documentation, advise on the appointment of a Registered Manager, and help ensure that your clinical governance framework meets the Fundamental Standards.

We'll advise on all regulatory matters relevant to establishment of your business and advise on the legal elements of the health policies that are required for the business.

Browne Jacobson can conduct a structured legal review of each policy, examining them against the applicable regulatory, statutory, and common law frameworks in England. This will include assessing compliance with CQC fundamental standards and registration requirements, NHS commissioning frameworks (including NHS England's Mental Health Implementation Plan), the Health and Social Care Act 2012 (as amended), the Mental Health Act 1983 (as amended by the Mental Health Act 2007), and any relevant NICE guidelines with legal or regulatory implications. A written legal opinion or review note will be produced for each policy, clearly flagging areas of legal risk, non-compliance, or ambiguity, together with recommended amendments.

As well as advice in relation to CQC, we'll support on all requirements under the Health and Care Act 2022, and NHS provider licence conditions if NHS-funded services are intended.

Any international healthcare provider establishing operations in the UK will require a bespoke suite of commercial contracts and terms governing its relationships with patients, referral partners, technology providers, clinical staff, and other third parties.

These documents are the legal architecture that underpins your entire operation, allocates risk, protects revenue, and ensures regulatory compliance. The contracts required will depend on your business model, but the suite will typically span: patient-facing documents, referral partner and intermediary arrangements, clinical and professional services agreements, technology and digital health contracts, supplier and third-party contracts, and corporate and investor documents.

Browne Jacobson can provide support across the full commercial contracts suite, including drafting from our precedent bank, adapting your existing documents, legal review and risk flagging, and negotiation support.

We'll advise on your governance framework for the business and ensure all legal requirements are met.

We'll work collaboratively with you to develop a robust governance framework. Browne Jacobson will review and, where necessary, draft or redraft to ensure the governance framework meets legal requirements, including the duty of candour, safe staffing obligations, safeguarding requirements, and directors' duties under the Companies Act 2006. A joint governance manual will be produced as a key deliverable.

Data protection compliance is a fundamental legal obligation for any healthcare provider operating in the UK. Given the sensitivity of patient health data, the regulatory framework is both demanding and fast-evolving.

Establishing robust data protection and information governance arrangements from the outset is therefore essential, particularly with a possible cross-border element depending on proposed operations. This includes:

  • Compliance with the UK GDPR and the Data Protection Act 2018.
  • Ensuring that cross-border transfers are governed by appropriate transfer mechanisms.
  • Reviewing Data Processing Agreements (DPAs) with referral partners, technology providers, and other data processors.
  • Advising on patient-facing privacy notices.
  • Advising on the Data (Use and Access) Act 2025 and its implications for digital health data sharing.
  • Advising on NHS Data Security and Protection (DSP) Toolkit requirements, relevant if you contract with the NHS.
  • ISO 27001 certification as a recommended best-practice information security framework, particularly where working with the NHS.

Understanding whether any element of your product or service offering falls within the scope of MHRA regulation is an essential early step.

This includes digital health tools, software platforms, or AI-driven functionality. The regulatory position isn't always straightforward, and the consequences of failing to register a regulated product, or of marketing a product with an incorrect classification, can be significant — including enforcement action, reputational risk, and potential liability.

We can advise on the current regulatory position and the circumstances in which MHRA registration would be triggered.

You will need to engage clinical and non-clinical staff in the UK. Employment contracts and relevant employment policies and procedures must be considered.

Clinical policies and procedures will be required for medical staff. Where you're engaging any overseas employees, immigration advice will be required to ensure they have the necessary permissions to work in the UK.

We can prepare employment contracts for clinical and non-clinical staff, and assist with preparing an employee handbook to include necessary policies and procedures (disciplinary, grievance, absence management, whistleblowing, family leave). We can provide specialist immigration advice as required.

Healthcare providers must comply with specific rules governing the advertising and promotion of health services in the UK.

This includes the Advertising Standards Authority (ASA) CAP and BCAP Codes, GMC, NMC, and other professional body guidance on advertising, and specific restrictions on claims made in relation to clinical outcomes or treatments. Patient-facing materials beyond privacy notices also require legal review.

We can review your marketing materials, website content, and patient communications to ensure compliance with ASA requirements and applicable professional standards, and advise on permissible claims in relation to your clinical services.

You will wish to protect your brand and proprietary technology in the UK. We can advise on this and also recommend patent attorneys as required.

If you're planning to partner or contract with the NHS, you will need advice on partnering and contracting arrangements, any necessary frameworks that you could utilise, contracting with ICBs and NHS Trusts, and access to the NHS patient choice framework.

Also, we can provide advice in relation to the NHS standard contracts, the potential risks and mitigations, and how you may wish to mark those up (where possible). It is more than likely that your NHS contracting partners would expect to use the NHS standard suite of contracts to engage your services.

We can advise on the NHS landscape and system, the expectations in relation to contracting, likely contracting partners, and the NHS patient choice framework. The system can be difficult to navigate but we'll guide and support you. We'll also support you to negotiate and finalise your contracts with NHS parties, and know the suite of NHS standard contracts well.

Most health providers will need to lease or acquire clinical or office premises in the UK. Healthcare premises are subject to specific planning use classes (Class E for health) and may require change of use consent.

Lease terms, break clauses, and service charges all require careful review. Your facilities will also need to be detailed in your CQC registration, so it's important to have these details early on.

Browne Jacobson can advise on the acquisition or leasing of UK premises, including healthcare-specific planning considerations, negotiation of heads of terms, and review and negotiation of commercial leases.

Establishing a UK subsidiary will give rise to UK tax considerations, including corporation tax registration, VAT registration (if required), and PAYE and National Insurance obligations for UK employees.

Pricing

Pricing will be discussed on a business-by-business basis according to your needs, but the following principles apply:

  • A pick-and-mix approach can be utilised - this is not an all-or-nothing package.
  • Fixed prices will be available to give you cost certainty.
  • We'll apply discounts the more areas we're advising you on.
  • The best value will be the comprehensive package of support.
  • We have tech experts and professionals who have worked in the health sector for many years who we can wrap into our service to give you an even more comprehensive entry package of support.
  • We can work with your local counsel and utilise existing documents, contracts and policies where possible.
  • Fee proposals will be provided following your discovery call.

How it works

  • Discovery: Initial scoping call with our health team.
  • Scoping: Agree scope and package (pick and mix from menu of services, or choose all).
  • Mobilisation: Dedicated Browne Jacobson team mobilised.
  • Delivery: Work commences.

Arrange a free discovery meeting to discuss your requirements

Frequently asked questions

Yes. If you will be delivering regulated activities, registration with the CQC is a legal requirement under the Health and Social Care Act 2008 before operations can commence. The registration process involves identifying a Registered Manager and providing supporting documentation evidencing required policies. Browne Jacobson can advise on registration requirements, assist in preparing the application, and help ensure your clinical governance framework meets the Fundamental Standards.

You can incorporate a new UK limited company at Companies House, or take advice on whether you can start up using an already established non-UK entity. Key considerations include the appropriate corporate structure (e.g. wholly owned subsidiary or standalone vehicle) and the composition of the board of directors. Our team can advise on the optimal structure for your specific business model and jurisdiction of origin.

Understanding whether any element of your product or service offering falls within the scope of MHRA regulation is an essential early step. This includes digital health tools, software platforms, or AI-driven functionality. The regulatory position is not always straightforward, and the consequences of failing to register a regulated product — or of marketing a product with an incorrect classification — can be significant, including enforcement action, reputational risk, and potential liability. We can advise on the current regulatory position and the circumstances in which MHRA registration would be triggered.

If you're planning to partner or contract with the NHS, you will need advice on partnering and contracting arrangements, any necessary frameworks, contracting with ICBs and NHS Trusts, and access to the NHS patient choice framework. It is more than likely that your NHS contracting partners would expect to use the NHS standard suite of contracts to engage your services. We can advise on the NHS landscape, the expectations in relation to contracting, and likely contracting partners. We will guide and support you through the process and know the suite of NHS standard contracts well.

Data protection compliance is a fundamental legal obligation. Healthcare providers operating in the UK must comply with the UK GDPR and the Data Protection Act 2018. Additional obligations include ensuring cross-border transfers are governed by appropriate mechanisms, reviewing Data Processing Agreements with partners and processors, providing patient-facing privacy notices, complying with the Data (Use and Access) Act 2025, and (if contracting with the NHS) meeting NHS Data Security and Protection Toolkit requirements.

Yes - a pick-and-mix approach can be utilised and this is not an all-or-nothing package. Fixed prices will be available to give you cost certainty, and we'll apply discounts the more workstreams we're advising you on, with the best value in the comprehensive package of support.

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