Artificial Intelligence and Data

Overview

The HTAi Interest Group for Artificial Intelligence and Data (AID) gathers HTAi members interested in the generation and use of data and/or AI for HTA. It provides an environment for education and training, communication and knowledge sharing, capacity building and collaboration.

Organization Information

Co-Chairs:

Rossella Di Bidino (Italy) – 2026-2029
Seye Abogunrin (Switzerland) – 2026-2029

Technical Officer: Linn Nathalie Støme, Norway

Interest Group Steering Committee

Seye Abogunrin (Switzerland) – 2026-2029
Rossella Di Bidino (Italy) – 2026-2029
Iben Fasterholdt (Denmark) – 2026-2029
Augusto Guerra (Brazil) – 2026-2029
Line Linstad (Norway) – 2026-2029
Smriti Raichand (Australia) – 2026-2029
Adam Skali (Morocco/Spain) – 2026-2029

Terms of Reference

Join IG

Contact our Technical Officer to find out how to become part of this interest group.

Linn Nathalie Støme
to.aid@htai.org

Overview

The importance of data in Health Technology Assessment (HTA) is increasing over time, as technological advances have given rise to innovative tools for collecting and recording information, and for generating and synthesizing evidence from a wide variety of settings in the real world, and oftentimes, even, in real time. Additionally, stakeholders have a better understanding of how access to innovative technologies can be facilitated and even accelerated. They are willing and even eager to consider the use of machine learning (ML) and artificial intelligence (AI) technologies to gain the advantage of more comprehensive evidence to inform decision-making.

The use of data and AI has been discussed for the past few years in the context of dossier submission for new technologies to enter the market across geographies, with draft guidance emerging across both sides of the Atlantic however, harmonization is needed on the methods and best practices to guide how high-quality data can be generated, how it can be incorporated and assessed in the context of HTA, and, indeed, in the overall context of improved resource allocation and improved access, including in the context of providing high quality healthcare services, and as captured in the sub-goal Sustainable Development Goal (SDG) for Universal Health Coverage (UHC) (SDG 3.8) of the United Nations.

The availability of big data (especially open data) and the new methods such a ML and AI provide unprecedented opportunities to combine data from different sources in a meaningful manner and to allow for assumptions to be explored in a detailed manner, incl. in the context of HTA. AI is also used as stand-alone health technology itself or used in other technologies.

The Artificial Intelligence and Data Interest Group (AID IG) was established in June 2026 by the HTAi Board of Directors as an evolution and re-focus of the existing Real World Evidence and AI Interest Group (RWE&AI IG).

Aims and Objectives

Goal: To provide a discussion forum where IG members can provide insights and make collective decisions about subjects related to the mission of the IG.

Activities: Enable the members to get into contact with each other and launch the topic of their interest within the framework of the IG mission, using mailing lists, LinkedIn groups or other methods.

The specific aims of the Interest Group are:

To educate evidence developers and assessors, including practitioners, researchers and regulators, on how AI and ML are/will be used, on the data generation and utilization in the context of regulatory and HTA dossiers; to identify and engage people with interest and expertise in data, AI and HTA and to explore further use in collaborative projects, incl. to facilitate cross-border and interdisciplinary collaboration and identify early cases of best practice;
To provide a discussion forum where IG members can provide insights, exchange ideas and make collective decisions about subjects related to the mission of the I so as to help the wider HTAi society, incl. other SIGs to better understand these concepts and to identify synergies, opportunities for cross-IGs collaboration and positioning, and, of course, to contribute towards the scientific development of members and the capacity building in relevant organization across the globe

Webinars

Join the conversation on Connecting on AI & Data: Meet the Team, Discuss the Priorities
Join the HTAi Artificial Intelligence and Data Interest Group for an open discussion led by co-chairs Seye Abogunrin and Rossella Di Bidino.
What to expect:
An inside look at the group’s mission and roadmap
Direct engagement with the Steering Committee – Adam Skali, Iben Fasterholdt, Line Lindstad, Smriti Raichand and Augusto Guerra
An open forum to share perspectives and shape upcoming initiatives
Two sessions are available to accommodate participants across different time zones.
September 28, 2026
08:00-09:00 GMT+2
16:00-17:00 GMT+2
Register here:
8.00 AM Webinar-https://us06web.zoom.us/webinar/register/WN_5NzKD_RmThW87ArCIBrI1A
4.00 PM Webinar – https://us06web.zoom.us/webinar/register/WN_yF5kYxCRRO-3zYDCJNKotw

Resources and Materials

Events

No upcoming events.

Real World Evidence & Artificial Intelligence (RWE&AI) Interest Group (2020-2026)

Compare and Contrast RWE Guidelines Across Decision-Makers including HTAs

View the Recording

April 28, 2021 – 7:00 a.m. MDT

Panelists:
Ashley Jaksa, Aetion (USA)

Session Details:
The main goal of this webinar is to promote integration and collaboration among RWEAI IG members, who are invited to speak about their projects and work.

Regulatory Interactions and Conditional Coverage (RICC) Interest Group (2018-2020)

Annual Meetings

RICC workshop (Saturday 15 June 2019) – “A Primer in Regulatory Interactions and Conditional Coverage – How to Generate Real World Evidence – A Modern Approach”

Resources and Materials

RICC Repository

The Regulatory Interactions and Conditional Coverage (RICC) Interest Group has developed the following repository of publicly available information. The primary objective of this repository is to provide a regularly updated bibliography of peer-reviewed literature on the key topics in scope of the Interest Group, namely:

Adaptive pathways
Early dialogue / scientific advice involving both regulators and HTA bodies
HTA-Regulatory Interactions relating to evidence development
Managed entry agreements (focussed on outcomes-based agreements)
Performance-linked Risk Sharing Agreements (PBRSAs)
Performance-linked Risk Sharing Agreements (PBRSAs)
Conditional treatment continuation (CTC)
Post-marketing additional data collection

Post-marketing additional data collection

Repository Manager: Michelle Mujoomdar (CADTH)

Information Specialist: David Kaunelis (CADTH)

Detail of the literature search methodology

The literature search was performed by an information specialist. Published literature was identified by searching the following bibliographic database: MEDLINE (1946- ) with in-process records & daily updates via Ovid. The search strategy was comprised of both controlled vocabulary, such as the National Library of Medicine’s MeSH (Medical Subject Headings), and keywords. The main search parameters were health technology assessment and regulatory concepts. Additional terms specific to the RICC key topics were also included, such as: coverage with evidence development, scientific advice, adaptive licensing, adaptive pathways, managed entry and conditional approval. A search of specific agencies contributing to this work (TLV, PBAC, NICE, HAS, G-BA and ZIN) was also incorporated into the strategy. No methodological filters were applied to limit retrieval. Retrieval was limited to English-language citations, published from January 1, 2015 to the present. The initial search was completed on February 4, 2016. A monthly alert has been established to update the search results.

2014

Baird et al. Accelerated access to innovative medicines for patients in need. Clin. Pharm Ther. 2014; 96: 559-571

Bergmann et al. Actual developments in European regulatory and health technology assessment of new cancer drugs: what does this mean for oncology in Europe? Ann. Oncology. 2014; 25: 303-306

Berntgen et al. Improving the Contribution of Regulatory Assessment Reports to Health Technology Assessments-A Collaboration between the European Medicines Agency and the European network for Health Technology Assessment. Value in Health. 2014 [Epub ahead of print]

Cuche M et al. Early dialogue with health technology assessment bodies: a European perspective. IJATC 2014; 30: 571-578

Elvidge S. EMA’s parallel advice workshop bridges regulatory and reimbursement divide. Nat. Rev. Drug Discovery. 2014; 13:8

Grainger D. Is this the real life? Is this just fantasy? Int. J. Technol. Assess. Health Care. 2014; 30:239-240Husereau et al. Adaptive approaches to licensing, health technology assessment, and introduction of drugs and devices. Int. J. Technol. Assess. Health Care. 2014; 30:241-249

Husereau et al. Adaptive approaches to licensing, health technology assessment, and introduction of drugs and devices. Int. J. Technol. Assess. Health Care. 2014; 30:241-249

Klemp M et al. Transcatheter aortic valve implantation and adaptive / progressive coverage. Int. J. Technol. Assess. Health Care. 2014; 30:250-251

Trusheim et al. The Janus initiative: A multi-stakeholder process and tool set for facilitating and quantifying Adaptive Licensing discussions. Health Policy and Technology. 2014; 3:241-247

Towse A. Presidents Message: Adaptive pathways to Value Assessment. ISPOR Connections. 2014; 20(5): 3

Tarricone R. et al. Generating appropriate clinical data for value assessment of medical devices: what role does regulation play? Expert Review of Pharmacoeconomics & Clinical Research. 2014; 14: 707-718

Uguen et al. Accelerating development, registration and access to medicines for rare diseases in the European Union through adaptive approaches: features and perspectives. Orphanet J Rare Dis. 2014; 9:20

Wonder M. What can be gained from increased early-stage interaction between regulators, payers and the pharmaceutical industry? Expert Rev Pharmacoecon Outcomes Res. 2014; 14:465-467

2013

Baird et al. Comparison of Stakeholder Metrics for Traditional and Adaptive Development and Licensing Approaches to Drug Development. Ther. Inn. Reg. Sci. 2013; 47:474-483

De Jong et al. Appropriate evidence for adaptive marketing authorization. Nat. Rev. Drug Discov. 2013; 12:647-648

Forda et al. Priorities for improving drug research, development and regulation. Nat. Rev. Drug Discov. 2013; 12:247-248 Technology Assessment. Value in Health. 2014 [Epub ahead of print]

Henshall et al. Understanding the Role and Evidence Expectations of Health Technology Assessment and Coverage/Payer Bodies: What Are They Looking for, and How and Why Does This Differ From What Regulators Require? Ther. Inn. Reg. Sci. 2013; 48:341-346

Tsoi et al. Harmonization of reimbursement and regulatory approval processes: a systematic review of international experiences, Expert Rev Pharmacoecon. Outcomes Res. 2013; 13:497-511

Wonder et al. Early scientific advice obtained simultaneously from regulators and payers: findings from a pilot study in Australia, Value in Health. 2013; 16:1067-1073

2012

Barker & Garner. Adaptive drug development and licensing. Regulatory Rapporteur. 2012; 9:13-14

Development. Ther. Inn. Reg. Sci. 2013; 47:474-483

Brekenridge et al. Medicines Regulation and Health Technology Assessment. Clin. Phar. Ther. 2012; 87: 152-154

Eichler et al. Adaptive Licensing: Taking the Next Step in the Evolution of Drug Approval. Nature. 2012; 91: 426-437

Frnsdal et al. Interaction initiatives between regulatory, health technology assessment and coverage bodies, and industry. Int. J. Technol. Assess. Health Care. 2012; 28:374-81

Liberti et al. Preparing for regulatory review and reimbursement decisions: a case for cooperation between regulatory authorities and health technology assessment agencies. Pharm. Med. 2012; 23:263-267

Messner & Tunis. Current and future state of FDA-CMS parallel reviews. Clin. Pharmacol. Ther. 2012; 91:383-385

2011

Backhouse et al. Early dialogue between the developers of new technologies and pricing and reimbursement agencies: a pilot study. Value in Health. 2011; 14:608-615

Barlas S. Pitting the FDA against CMS: the good, the bad and the ugly about “parallel review”. Biotechnol Health. 2011; 8:29-30

Eichler et al. Bridging the efficacy-effectiveness gap: a regulator’s perspective on addressing variability of drug response. Nat. Rev. Drug Discov. 2011; 10:495-506

Henshall et al. Interactions between HTA, coverage and regulatory processes: emerging issues, goals and opportunities. Int. J. Technol. Assess. Health Care; 2011; 27:253-60.

Pignatti et al. Regulators, payers and prescribers: can we fill the gaps? The Lancet Oncology. 2011; 12: 930-931

2010

Eichler et al. Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers. Nat. Rev. Drug Discov. 2010; 9:277-91.

2009 – 1999

Battista et al. Health technology assessment and the regulation of medical devices and procedures in Quebec. Int. J. Technol. Assess. Health Care. 1999; 15:593-601

Wang S and Smith J. Potential legal barriers to increasing CMS/FDA collaboration: the law of trade secrets and related considerations. Food and Drug Law Journal. 2003; 58:613-627

Overview

Organization Information

Join IG

Overview

Aims and Objectives

Webinars

Resources and Materials

Events

No upcoming events.

Real World Evidence & Artificial Intelligence (RWE&AI) Interest Group (2020-2026)

Compare and Contrast RWE Guidelines Across Decision-Makers including HTAs

Regulatory Interactions and Conditional Coverage (RICC) Interest Group (2018-2020)

Annual Meetings

Resources and Materials

RICC Repository

January 2018 – May 2018

2017

2016

2015

2014

2013

2012

2011

2010

2009 – 1999