All Insights

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

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

Advertising, marketing authorisation applications and imports are among the areas targeted by the draft proposals
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

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
Life Sciences and Healthcare

Judicial review highlights pharmaceutical industry concerns over VPAS in UK

Negotiations for new voluntary scheme being challenged by industry body as old scheme is criticised for amount levied on suppliers
Regulatory Outlook

Products | UK Regulatory Outlook June 2023

General Product Safety Regulation enters into force | Council of the EU adopt position on new Product Liability Directive |
Life Sciences and Healthcare

UK gives guidance for manufacturers on reporting adverse SaMD incidents

Businesses should consult the guidelines and familiarise themselves with the issues to report and systems to implement
Life Sciences and Healthcare

Use of trade mark for food supplements does not amount to genuine use for pharma products

Food supplements are not considered as a sub-set of pharmaceutical products in class 5 for proving genuine trade mark use
Life Sciences and Healthcare

Pharma impacted by new EU packaging and packaging waste proposals

The European Commission concludes its feedback period from stakeholders on its draft regulation