The European Commission (EC) has proposed new legislation directed toward formation of a European Health Data Space (EHDS), which is nominally intended to address some perceived gaps in the General Data Protection Regulation (GDPR). While this legislative proposal seems to interact with both the GDPR and pending EU legislation on artificial intelligence, the EHDS takes on the massive challenge of compulsory interoperability of electronic health records (EHRs). The EC unveiled the proposal with an emphasis on health data accessibility, although both the European Council and the European Parliament will now have their say over how the legislation will ultimately read.
In launching the European Health Data Space May 3, the European Commission (EC) heralded it as “a fundamental game-changer for the digital transformation of health care in the EU.”
Making it a done deal, the European Council adopted proposals April 12 to ensure the continued long-term supply of medicines from Great Britain to Northern Ireland and to address supply concerns in Cyprus, Ireland and Malta, which historically have been dependent on drugs from the U.K.
The European Commission has acted to thwart cybersecurity risks with a proposed cybersecurity regulation and separate proposal for information security. What is not clear, however, from these proposals is whether they would interact with existing EU rules governing cybersecurity for medical devices, raising the prospect that medical technologies will be subject duplicate oversight for cybersecurity.
Building on its partnership with the World Health Organization (WHO) to improve access in Sub-Saharan Africa to vaccines, drugs and medical technologies, the EU committed at least €24.5 million (nearly US$27 million) to fund projects aimed at tackling some of the barriers to that access.
The indirect impact of the Russian invasion of Ukraine on the life sciences sector continues to grow, as the West responds with more and more sanctions against Russia. In one of the latest moves, the European Commission announced March 4 that it is suspending cooperation with Russian entities in research, science and innovation.
LONDON – The European Commission (EC) has put forward proposals for a Data Act that is intended to both give users greater rights over their own data and allow greater third-party access. The Act sets out who can use and access data generated in the EU across all sectors of the economy. It is pitched by the EC as opening the doors to an under-used resource that will in turn promote research and innovation and create new markets in information services.
The effect of the COVID-19 pandemic on the roll-out of European Union’s new med-tech regulations has sparked concerns about in vitro diagnostic availability, but relief from compliance deadlines has now been achieved. The European Parliament and the European Council have agreed to ease the compliance dates of the In Vitro Diagnostic Regulation (IVDR).
COVID-19 kept its grip on the world in 2021 as one new variant after another created new waves of infection, forcing regulatory officials to face ongoing political and logistical pressures in dealing with drug and vaccine approvals, mergers and acquisitions, manufacturing issues and demands for pricing reforms.
Illumina Inc.’s troubled takeover of Grail Inc. is facing further backlash from the European Commission (EC) after the regulator issued a statement of objections to the companies following their alleged breach of the EU Merger Regulation. Illumina’s acquisition of Grail has faced scrutiny from regulators since it was first announced due to concerns the deal could curb innovation and competition.
