CMS proposes a faster pathway for manufacturers to obtain Medicare coverage of new medical devices.
US CMS Newsroom · United StatesFinal rules amend price transparency requirements for non-grandfathered group and individual health plans, standardizing machine-readable pricing files with new data elements and reporting thresholds.
US Federal Register - HHS Rules · United StatesProposed 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 StatesNICE 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 · UKCommission 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 to support early information provision for 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 · PortugalCollection of joint clinical assessment reports, procedural guidance for joint scientific consultations on devices and IVDs, and methodological Q&As for HTA dossier preparation.
EU HTA Regulation Implementation · EU-wideCollection of joint clinical assessment reports, procedural guidance for scientific consultations on devices and IVDs, AI principles, and methodological FAQs for HTA implementation.
EU HTA Regulation Implementation · EU-wideRevised draft guidance on manufacturer communications of health care economic information about approved drugs and devices to payors and formulary committees.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 StatesUpdated 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 · UKJoint Clinical Assessments under the HTA Regulation now extend to selected high-risk medical devices and in-vitro diagnostics.
European Commission · 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 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 · UKGuidance clarifying joint clinical assessment procedures under the EU HTA Regulation.
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 · UKLithuania's health technology assessment body reports receipt and review of 6 new applications and continuation of 4 existing applications in October.
Lithuania VVKT · LithuaniaThe European Commission has selected the first medical devices for joint clinical assessment under the HTA Regulation.
EC Public Health · EU-wideIQWiG and LSE researchers discuss the first Joint Clinical Assessment under the EU HTA Regulation and its implications for evidence generation.
IQWiG (German HTA) · GermanyNICE published guidance recommending NHS access to specialist devices that preserve donated livers and lungs outside the body for transplantation.
UK NICE · UKSUKL updated web submission forms for pharmaceutical reimbursement applications to include a section on joint clinical health technology assessment under EU HTA Regulation 2021/2282.
Czechia SUKL · Czech RepublicMHRA 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) · SpainLearn how NICE Advice’s system engagement service helps life sciences companies spot NHS adoption barriers before they become roadblocks. Senior adviser for NICE Advice You’ve developed an innovative medicine, device,...
UK NICE · UKAEMPS 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) · SpainThe HTA Member State Coordination Group has adopted guiding principles on data transparency.
EC Public Health · EU-wideDanish Medicines Council announces collaboration with DARE on real-world data initiatives.
Medicinrådet (Danish Medicines Council) · DenmarkNews 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-wide