- Corporate, Commercial
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New technologies, digital services and other innovations are transforming health and social care and offering the potential to deliver significant benefits to both patients and taxpayers.
If you’re thinking of starting a healthcare business, see our dedicated page for Healthcare startups which covers in more detail some of the key issues you’ll need to consider from a legal, commercial and regulatory perspective.
Technology and innovation will play a key role in the ability of the health and social care sector to deliver more efficient, flexible and higher quality services.
The NHS should “make better use of digital services and technology to transform patients’ and their carers’ access to and use of health and care, including online access to their personal health records.” (The Government’s mandate to NHS England for 2017-18)
Alongside great opportunities, the rise of digital and healthtech comes with its own unique set of challenges for the public health and care organisations and technology companies and innovators participating in the sector.
- Setting up your business and corporate structure – selecting the right entity (company, LLP, CIC), company incorporation, shareholders and partnership agreements and related advice.
- Regulatory compliance – guiding you through the alphabet soup of health regulators – CQC (HIW in Wales), GDC, GMC, GPhC, HCPC, HFEA, HSE, MHRA, NHSX, NHS Digital, NMC & etc.
- Data protection – GDPR & DPA compliance including drafting Privacy/Transparency Notices, advice on data registries and cloud computing, international data transfers, AI/machine learning, access to health data held by public bodies and clinical research projects.
- Information governance – ICO regulatory compliance, NHS information governance rules and Freedom of Information (FOI).
- Apps and software – app development agreements and End User Licenses (EULA), Software as a Service agreements (SaaS), medical device regulation (can be applicable for software) and accessing the NHS apps library.
- Medical Devices and In Vitro Diagnostics – compliance with MHRA requirements, CE marking requirements and advice on MDR and IVDR.
- Intellectual property – protecting what’s yours through non-disclosure agreements (NDAs), trade mark applications, design registrations, copyright and other IP such as licensing and assignments.
- Marketing and ethics– lawful use of email databases for marketing (PECR) and advice on ethical/regulatory restrictions on advertising in the health sector.
- Contracting with consumers and patients (B2C) – helping you prepare terms and conditions with your customers, compliant with Distance Selling Regulations and consumer rights law.
- Contracting with third parties (B2B) – preparing commercial terms and contracts for you to use with your suppliers and business customers.
- Pre-seed, seed and series A investments – helping to protect your interests when raising funds for your business from investors.
- Employment – providing advice on employee contracts, subcontracting and freelancer arrangements, directors service contracts and all things ‘staff’ related.
- Selling to public bodies – engaging with the NHS and public sector frameworks and advice on procurement regulations.
- Property and premises– establishing clinics and advice on leases, licences and tenancies.
- Disputes – should things go wrong with customers, partners or suppliers, our experienced dispute resolution team can guide you through mediation, arbitration and litigation.
- Acting for a UK based pharmaceutical company in relation to the acquisition of a drug research, development and licensing business with a large portfolio of on-going research projects, IP and product dossiers.
- Advising Manchester Academic Health and Science Network on the “Datawell” project to identify a partner to work with the network to develop, implement and exploit a new IT solution to share data across network members. This project uses the new innovation partnership procurement procedure under the Public Contracts Regulations 2015
- Advising on development of healthcare apps for patients, including advising NHS Northern England Strategic Clinical Networks on its Deciding Right app for making care decisions and NHS South East Commissioning Support Unit on its Health Help Now app to enable users to find the right service for their health needs.
- Advising NHS Foundation Trusts in the North West and Yorkshire on contracts for Clinical Information Services, Picture Archive and Communications Systems and Electronic Patients Records systems.
- Advising the EU CEN working group on the development of an electronic coding and traceability framework for human tissue and cells across the EU.
- Advising an independent hospital on IT physical infrastructure design and consultation services, IT security consultancy services, and IT data centre services.
- Advising an NHS Commissioning Support Unit on an IT contract for the provision of Business Intelligence Servers and the hosting of a new Oracle platform called off from the G-Cloud framework.
- Advising SH:24, a start-up social enterprise working in Lambeth and Southwark on provision of online sexual and reproductive health services integrated into existing local NHS services.
- Advising all the major acute NHS Trusts across the Yorkshire and Humber area to procure the provision and maintenance of telemedicine solutions to enable remote diagnosis of Stroke patients.
- Advising in relation to the first licence application to use gene editing technologies in human embryos.
- Advising companies on the intellectual property protection of medical devices, and the licensing and exploitation of that intellectual property.
- Drafting written representations and representing IVF clinics before the Human Fertilisation and Embryology Authority Licence Committee and Appeal Committee.
Hempsons are regularly invited to speak at sector events on a range of topics, including:
- London Tech Week – ‘Things you need to know about information governance to sell healthtech products into the NHS’
- Northern Powerhouse Funding Workshop – ‘The funding Journey’
- London Medtech SME Brexit Round Table – ‘Brexit and the implications for London MedTech SME Life Sciences companies’
- SEHTA Digital Health Regulations seminar – ‘Information governance issues when working with health data’.