Health Technology Assessment, or HTA, is the structured evaluation of the properties and effects of a health technology, such as a medicine, device, or procedure. It considers clinical effectiveness, safety, and often cost effectiveness and budget impact, in order to inform decisions on pricing, reimbursement, and coverage. National bodies such as Germany's G-BA, the UK's NICE, and France's HAS carry out HTA in different ways. At EU level, the HTA Regulation, Regulation (EU) 2021/2282, introduced joint clinical assessments for certain new medicines and high-risk medical devices, starting to apply in January 2025 and phasing in over several years. The aim is to reduce duplication of clinical assessment across member states while leaving pricing and reimbursement decisions to national authorities.
What is Health Technology Assessment?
Health Technology Assessment evaluates the clinical and economic value of health technologies to inform reimbursement and coverage decisions.
What is the EU HTA Regulation?
The HTA Regulation (EU) 2021/2282 introduced joint clinical assessments at EU level for certain medicines and high-risk devices, phasing in from January 2025, while national bodies keep control of pricing and reimbursement.
Regulatory Alignment for Predictable and Immediate Device Coverage Pathway (CMS-3487-NC) Procedural Notice Inviting Comment
CMS proposes a faster pathway for manufacturers to obtain Medicare coverage of new medical devices.
US CMS Newsroom · United StatesHealth Technology Assessment: Commission adopts rules for joint clinical assessments of medical devices and in vitro diagnostic medical devices
Commission adopts rules enabling joint clinical assessments of medical devices and IVDs under the HTA Regulation.
EC Public Health · EU-wideFrequently Asked Questions on SiNATS Review: First Answers Now Available
INFARMED publishes initial FAQ clarifying changes to Portugal's National Health Technology Assessment System (SiNATS) introduced by Decree-Law 118/2026.
Portugal INFARMED · PortugalEU HTA Regulation: JCA reports and procedural guidance
Compilation of Joint Clinical Assessment reports, procedural guidance on AI use in HTA dossiers, data transparency principles, and methodological FAQs for medical devices and IVDs.
EU HTA Regulation Implementation · EU-wideMedicare and Medicaid Programs; Interoperability Standards and Prior Authorization for Drugs for Medicare Advantage, Medicaid, CHIP, and Qualified Health Plans
Proposed requirements for electronic prior authorization for drugs and extended interoperability standards across Medicare Advantage, Medicaid, CHIP, and QHP issuers.
US Federal Register - CMS Rules · United StatesGermany DiGA Performance Reporting Mandatory
DiGA manufacturers must implement continuous performance measurement (AbEM) and report to BfArM; up to 20% of reimbursement price becomes outcome-dependent.
BfArM DiGA Fast Track · GermanyNICE evidence standards framework for digital care technologies
NICE adapts its evidence standards framework for digital health technologies to support decision-making for digital care technologies in adult social care.
UK NICE · UKGuidance: The Innovative Devices Access Pathway (IDAP)
IDAP pilot accelerates development and market integration of innovative medical devices addressing unmet NHS clinical needs.
UK MHRA · UK