LONDON – There has been a lukewarm reception from the industry to the latest developments in the plan to establish a European health technology assessment (HTA) agency, with concerns from pharma that member states will be able to pick and choose whether to apply joint evaluations in national reimbursement and access negotiations.

PARIS – In France, the Haute Autorité de Santé, or National Health Authority (HAS), recently reported the entry into force of a new plan for "temporary" adoption under social security for innovative medical devices. The aim is to speed up access to the French insurance reimbursement market for medical technology addressing unmet or poorly met clinical needs in the context of serious or rare conditions, or which help disability in France.

As cyberattacks on U.S. hospitals continue to increase with health care’s growing reliance on technology, a new report from the U.S. Office of Inspector General (OIG) has flagged Medicare’s requirements for being silent on the cybersecurity of networked medical devices. The OIG’s study found hospitals are not required to identify networked device cybersecurity in their emergency preparedness risk assessments, and as a result, they don’t include this information “very often.”

The U.S. Senate and the House of Representatives have reintroduced the Verifying Leading-edge IVCT Development (VALID) Act, a bill that would authorize the FDA to regulate lab-developed tests (LDT). The question of the agency’s statutory authority to regulate LDTs is part of a long-running debate, but the immediate question is whether Congress will see fit to deal with the question this year rather than wait until 2022, when the next device user fee will require legislative authorization.

The FDA’s device center recently updated its guidance for testing and labeling of devices for compatibility with magnetic resonance (MR) fields. Some items, such as orthopedic plates and screws, might not have been evaluated for compatibility up to now. The FDA’s Sunder Rajan said that existing 510(k) and PMA devices are grandfathered in under the legacy policy, but that all implants will have to be evaluated for MRI compatibility going forward, even devices not previously subject to testing.

TORONTO – Health Canada has proposed a single regulatory framework for medical device and drug clinical trials after broad industry consultation and a hard line drawn by the COVID-19 pandemic for a more streamlined system.

LONDON – The U.K. is setting up a service for developers and users of artificial intelligence (AI) to provide a single source of advice covering all requirements for the technology, from clinical research to regulatory scrutiny, health technology evaluation and through to commissioning.