Legal

  • What clinical trial sponsors need to know about anonymisation and pseudonymisation of data

    By Melissa Hall, Legal Director in MFMac’s Healthcare & Life Sciences team With the healthcare industry relying heavily on data for medical research and surveillance studies, it is critically important that sponsors, study sites and CROs know when data falls within the remit of 'personal data', which brings with it additional compliance requirements. Earlier this [...]

  • Personalised treatments to deliver specialised care to patients more quickly

    Hospitals in the UK can now make personalised cancer treatments and gene therapies on site, potentially cutting delays from weeks or months to just days. The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025, which came into force today (23 July), make the UK the first country with a dedicated legal framework [...]

  • UK to ban ransom payments by public bodies

    The UK government plans to ban public bodies from paying ransoms to hackers, while private companies must inform authorities if they intend to meet ransom demands. The measures were announced on Tuesday by home office security minister Dan Jarvis and are intended to signal to cybercriminals that the UK is united in its stance against [...]

  • MHRA to speed up access to overseas-approved devices

    Patients in the UK will gain faster access to medical devices approved in trusted countries under new plans from the medicines regulator MHRA. The Medicines and Healthcare products Regulatory Agency has outlined steps to streamline routes to market, including a planned consultation on the indefinite recognition of CE-marked devices – those meeting European safety standards [...]

  • New UK ICO guidance and updates from Europe on anonymisation

    By Sharon Lamb, Lorraine Maisnier-Boché, and Bella North, McDermott Will & Emory What new guidance from the UK Information Commissioner’s Office (ICO) on anonymisation means for healthcare and life sciences companies. Harnessing health data is a key priority for life sciences companies as it enables more effective scientific research, better tailored clinical trials and investigations, [...]

  • McDermott advises Great Point Partners on financing of MLM‘s acquisition of Cytespace Africa Laboratories

    McDermott Will & Emery has advised Great Point Partners (GPP) on the financing of the acquisition of Cytespace Africa Laboratories by MLM Medical Labs (MLM), a portfolio company of GPP. With this strategic acquisition MLM expands their global footprint into South Africa. MLM Medical Labs headquartered in Mönchengladbach, Germany, with additional laboratories in Memphis, Tennessee, [...]

  • UK joins new global AI healthcare network

    The UK has become the first country to join a new international network of health regulators focused on the safe and effective use of AI in healthcare. The Medicines and Healthcare products Regulatory Agency (MHRA) joined the HealthAI Global Regulatory Network on 24 June as a founding ‘pioneer’ member, placing the UK at the centre [...]

  • The cyber security charter is a start. Now the NHS must enforce it

    By Trevor Dearing, Director of Critical Infrastructure at Illumio On 15th May, NHS England launched its new voluntary cyber security charter for suppliers. With it, the NHS is sending out a strong message: cybersecurity is a shared responsibility, and suppliers are responsible for improving resilience. The charter outlines eight security pledges that should be in [...]

  • ICO fines 23andMe £2.31 million for failing to protect UK users’ genetic data

    The Information Commissioner’s Office (ICO) has fined genetic testing company 23andMe £2.31 million for failing to implement appropriate security measures to protect the personal information of UK users, following a large-scale cyber attack in 2023. The penalty follows a joint investigation conducted by the ICO and the Office of the Privacy Commissioner of Canada. Between [...]

  • US health secretary Robert F. Kennedy Jr sacks entire CDC vaccine panel in major overhaul

    US health secretary Robert F. Kennedy Jr has dismissed all 17 members of the Centers for Disease Control and Prevention’s (CDC) vaccine advisory panel, in a move that has drawn widespread criticism from public health experts. The decision affects the Advisory Committee on Immunization Practices (ACIP), an independent panel of public health and medical experts [...]