New Health Tech Assessment Guidelines

The law will allow EU member states to conduct collaborative clinical assessments.

The European Council has approved a new, harmonized regulation on health technology assessments that would apply to all EU member states.

Cooperative clinical evaluations and joint scientific discussions on health technology will be possible between EU member states under the EU Health Technology Assessment (HTA), allowing for more fast assessments of healthcare innovations.

Key information will be shared with national health authorities across member states, resulting in only one healthcare technology assessment submission at the EU level for a specific product from a healthcare technology company.

Why Does It Matter?

To support policy decision-making, health technology assessment assesses the social, economic, organizational, and ethical concerns of a health intervention or health technology.

The new rule is designed to make it easier for health tech businesses to submit their applications and to enhance access to medications and medical equipment.

Increasing the identification and adoption of safe and effective healthcare technologies by patients, healthcare systems, and healthcare professionals by regulating and harmonizing healthcare technology assessment across EU member states is intended to reduce the administrative burden on innovators and increase the identification and adoption of safe and effective healthcare technologies by patients, healthcare systems, and healthcare professionals.

The Overall Context

The HTA’s added value has been questioned by industry organization Med Tech Europe.

The group expressed worries in March that the new law could obstruct regulatory evaluations under the Medical Device Regulation (MDR), which went into effect in May 2021 after a year’s delay due to COVID-19.

“This rule will create a new regime of joint clinical evaluations on medical technologies, without identifying a clear aim for undertaking such assessments at EU level,” Med Tech Europe CEO Serge Bernasconi stated in a statement on the organization’s website.

If future joint clinical assessment reports are to have any hope of actually enabling wider patient access to medical technology innovation, all member states must agree on a clear and common purpose for such EU-level work.”

In The Books

“The approval of this law is another evidence of how EU countries, when acting together, can achieve very practical outcomes for their inhabitants,” said Janez Poklukar, Slovenia’s minister of health.

This new law will benefit patients, health-tech manufacturers, and our healthcare systems.

“EU regulators just took a major step forward towards the harmonization of health technology assessments across EU member states, with positive implications for healthcare technology innovators and the general public in need of safe and effective health and care services,” said Isabel Van De Keere, program director at the Digital Medicine Society (DiME).

Collaboration between healthcare regulators, policymakers, and healthcare technology developers across regions is the only path ahead toward an accessible, effective, and fair healthcare system, as we saw throughout the epidemic.