All Insights

Regulatory and compliance

The next milestone approaches in the UK NHS net zero supplier roadmap

From April 2024, the NHS will proportionately extend the requirement for suppliers to prepare Carbon Reduction Plans to all procurements
Life Sciences and Healthcare

Using health data for R&D and AI: will new legislation make this possible in Germany?

The new health-data bill currently debated by the German lawmakers could be adopted this year and apply from early 2024
Life Sciences and Healthcare

Digital therapeutics in Europe: what is the state of play?

The regulatory landscape varies, but the potential for the sector is immense
IT and data

How the European Court of Justice is shaping health data anonymisation

A recent ruling gives valuable legal guidance on personal data but what are the practical implications for healthcare?
Life Sciences and Healthcare

Sunshine Act: introducing a transparent healthcare system

Law no. 62 of 3 May 2022, "Provisions on the transparency of relations between companies, professionals operating in the health
Life Sciences and Healthcare

EU's 'flexible' pharma reforms likely to require fine-tuning to address uncertainties

The reduction of the regulatory data protection period and wholesale distribution changes raise some industry concern
Life Sciences and Healthcare

EU to reform rules for drug-device combinations, product information and pharmacovigilance

The proposal's eight-week consultation has allowed the sector to assess the draft legislation in these and other areas
Life Sciences and Healthcare

EU pharmaceutical reforms to overhaul marketing and manufacturing rules

A dvertising, marketing authorisation applications and imports are among the areas targeted by the draft proposals
Life Sciences and Healthcare

Polish reimbursement law changes

A bill to amend the Act on the Reimbursement of Medicines and Certain Other Acts ('the Reimbursement Bill') is pending
Artificial intelligence

What risks need to be considered by a UK business using artificial intelligence?

An overview of the legal and regulatory risks arising from AI deployment published in our article in Compliance & Risk
Regulatory and compliance

UK government heralds 'indefinite' CE marking recognition in GB market

Businesses will still need to look carefully at regulations and determine if a UKCA or CE mark is more appropriate
Digitalisation

Neurotechnology advances pose discriminatory and privacy risks, warns the UK's ICO

The global brain-monitoring technology market could be worth $17.1bn by 2026 but will bring ethical and legal challenges