Market access and reimbursement decide whether an authorised product reaches patients and how it is paid for. Health Technology Assessment bodies evaluate clinical and economic value, the EU HTA Regulation now provides joint clinical assessments for certain medicines and high-risk devices, and pricing and coverage decisions still vary widely by country.
CMS proposes a faster pathway for manufacturers to obtain Medicare coverage of new medical devices.
US CMS Newsroom · United StatesCommission adopts rules enabling joint clinical assessments of medical devices and IVDs under the HTA Regulation.
EC Public Health · EU-wideUpdated guidance and eligibility tool published for early information submission in joint clinical assessments under the EU HTA Regulation.
EC Public Health · EU-wideINFARMED publishes initial FAQ clarifying changes to Portugal's National Health Technology Assessment System (SiNATS) introduced by Decree-Law 118/2026.
Portugal INFARMED · PortugalProposed 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 StatesDiGA 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 adapts its evidence standards framework for digital health technologies to support decision-making for digital care technologies in adult social care.
UK NICE · UKIDAP pilot accelerates development and market integration of innovative medical devices addressing unmet NHS clinical needs.
UK MHRA · UKDiGA reimbursement shifts to outcome-based pricing with up to 20% contingent on demonstrated healthcare effects; insurer activation codes reduced to 2-day requirement.
BfArM DiGA Fast Track · GermanyCompilation 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EU HTA Regulation Implementation · EU-wideRevised draft guidance on manufacturer communications of health care economic information about approved drugs and devices to payors and formulary committees.
US Federal Register - FDA Guidance Notices · United StatesJoint Clinical Assessments under the HTA Regulation now extend to selected high-risk medical devices and in-vitro diagnostics.
European Commission · EU-wideUpdated guidance on methodology and procedure for joint clinical assessments under the EU HTA Regulation.
EC Public Health · EU-wideGuidance clarifying methodological and procedural requirements for joint clinical assessments under the EU HTA Regulation.
EC Public Health · EU-wideNICE invites input on adopting a new EQ-5D-5L value set to improve health-related quality-of-life assessments in treatment evaluation.
UK NICE · UKGuidance clarifying joint clinical assessment procedures under the EU HTA Regulation.
EU HTA Regulation Implementation · EU-wideFactsheets on joint clinical assessment and scientific consultation procedures under the EU HTA Regulation, plus implementation guidance and analysis of regional cooperation structures.
EU HTA Regulation Implementation · EU-wideNICE recommends offering pregnancy-specific artificial pancreas devices to women with type 1 diabetes who are pregnant or planning pregnancy.
UK NICE · UKNICE recommends an online therapy programme for people aged 16 and over with eating disorders awaiting specialist NHS treatment.
UK NICE · UKNICE conditionally recommends five AI technologies as decision-support tools during bowel examinations to improve early detection of precancerous growths.
UK NICE · UKMHRA and NICE establish a programme to use real-world evidence in regulatory and health technology assessment decisions across product lifecycles.
UK MHRA · UKAEMPS establishes governance structure and implementation roadmap for coordinated application of the new European HTA framework.
AEMPS (Spanish Medicine Agency) · SpainAEMPS will serve as Medicine Evaluation Office and participate in governance of new Health Technology Assessment System aligned with EU Regulation 2021/2282.
AEMPS (Spanish Medicine Agency) · SpainGeneral Principles on the use of Artificial Intelligence in the preparation of the JCA dossier Procedural Guidance for Joint Scientific Consultations (JSC) on Medical Devices (MD) and In Vitro Diagnostic Medical Devic...
EU HTA Regulation Implementation · EU-wideThe HTA Member State Coordination Group has adopted guiding principles on data transparency.
EC Public Health · EU-wideNews announcement 7 January 2026 Health Technology Assessment: New opportunity to apply for Joint Scientific Consultations Health Technology Assessment: New opportunity to apply for Joint Scientific Consultations 1 mi...
EC Public Health · EU-wideNews announcement 8 December 2025 Updated rolling plan - Implementation of the Regulation on health technology assessment (December 2025) Updated rolling plan - Implementation of the Regulation on health technology as...
EC Public Health · EU-wideNews announcement 2 December 2025 Health Technology Assessment – 2026 Work Programme adopted Health Technology Assessment – 2026 Work Programme adopted 1 min read
EC Public Health · EU-wideThe UK MHRA announces the first investigational products enrolled in the Innovative Licensing and Access Pathway, enabling early-stage developer engagement with regulators and HTA bodies.
UK MHRA · UKTheRegulation (EU) 2021/2282 on health technology assessment(HTAR) entered into force on 11 January 2022 and applies from 12 January 2025.
EU HTA Regulation Implementation · EU-wideNews announcement 2 September 2025 Updated - List of ongoing joint clinical assessments 1 min read
EU HTA Regulation Implementation · EU-wideDanish Medicines Council launches two pilot projects with Danish Alliance for Real-World Evidence to analyse real-world effectiveness of recommended cancer medicines in Danish clinical practice.
Medicinrådet (Danish Medicines Council) · Denmark