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Dear Sir or Madam,

I wanted to follow up on my previous e-mail and kindly ask, if it is possible to forward our request to the department or person responsible for health technology assessments of digital health technologies in your country.

Thank you so much for your time and efforts.

Best wishes,

Cornelia

____________________________________________
PD Dr. Cornelia Henschke

Dept. Health Care Management, Technische Universität Berlin

Berlin Centre for Health Economics Research (BerlinHECOR)

Straße des 17. Juni 135, H80 | 10623 Berlin | Germany
Phone: ++49-30-314-28703

Von: Henschke, Cornelia, Dr.
Gesendet: Freitag, 3. Mai 2024 12:05
An: [email protected]
Cc: Rödiger, Hendrikje
Betreff: Horizon Europe project 'ASSESS-Digital Health Technologies' - Request for support

Dear Sir or Madam,

As you may know, the ‘ASSESS-DHT – Development and harmonisation of methodologies for assessing digital health technologies in Europe’ project – funded by the European Commission –has started its work at the beginning of this year. Further information can be found at the website of ASSESS-DHT (https://assess-dht.eu/).

As one of the first work packages, the Berlin University of Technology (TUB) is in the process of reviewing frameworks/ guidance documents/ guidelines for the assessment of digital health technologies (DHT).

The intention is to identify assessment frameworks/guidelines/guidance for DHTs that categorise different DHTs into groups/levels/tiers based on certain criteria (risk, function …) in order to assign appropriate evidence standards. This may include also methodological guidance and evidence requirements/submission templates for assessing DHTs, including specific DHTs such as − but not limited to − eHealth, AI-based health technologies, digital health applications/m-health. However, documents relevant to the assessment of medical devices including DHTs may also fall within this scope.

To this end, TUB is asking INAHTA/EUnetHTA members to fill in a short questionnaire by 17^th May 2024. Please complete the attached questionnaire or forward it to the appropriate person in your organization and return it to us. If you cannot answer all the questions, you are welcome to answer some of them. Based on the answers we might get back and ask for further clarifications.

ASSESS DHT is partnering with another EC funded project on DHT to engage with HTA agencies. In order to minimise efforts for HTA agencies, we will share frameworks and documents requested by us with EDiHTA (European Digital Health Technology Assessment: https://edihta-project.eu/). Attached you can find the collaboration agreement of ASSESS DHT + EDiHTA.

Please note that in the last part of the questionnaire the Big Data Unit of the Andalusian public Progress and Health Foundation (Big Data-FPS) requests a nomination of an expert specialized in artificial intelligence (AI) from your agency to participate in an online Delphi Panel.

If you have any questions or need further information, please don’t hesitate to contact us.

Thank you in advance and all the best from Berlin,

Kind regards,

Cornelia

____________________________________________
PD Dr. Cornelia Henschke

Dept. Health Care Management, Technische Universität Berlin

Berlin Centre for Health Economics Research (BerlinHECOR)

Straße des 17. Juni 135, H80 | 10623 Berlin | Germany
Phone: ++49-30-314-28703

EDiHTA-ASSESS_Presentation.pdf

EDiHTA + ASSESS DHT: The new EU-funded projects on a mission to revolutionise the European HTA landscape.

Rome, IT / Bonn, DE

EDiHTA and ASSESS DHT, the two projects recently funded under the Horizon Europe call HORIZON-HLTH-2023-IND-06-07 - Development and harmonisation of methodologies for assessing digital health technologies in Europe join forces to revolutionise the assessment of digital health technologies (DHTs) across Europe.

Digital health technologies (DHTs) are expected to improve healthcare quality and delivery across European countries, while also ensuring the long-term viability of Europe’s healthcare systems, but existing Health Technology Assessment (HTA) methodologies are unable to capture the real added value of DHTs. Both, EDiHTA and ASSESS DHT will address the methodological challenges of assessing DHTs, including their added value and health benefits for patients and the digital transformation of health systems.

EDiHTA: The first European Digital Health Technology Assessment framework co- created by all stakeholders in the European Health Ecosystem. EDiHTA will be the first flexible, inclusive, validated and ready-for- use European HTA framework reaching Technology Readiness Level (TRL) 6-7, allowing the assessment of different DHTs (e.g. telemedicine, mApps, AI) at different TRLs, territorial levels (national, regional and local) and perspectives (e.g. payer, society, hospital). All relevant stakeholders will contribute to its design, development and validation. The digital framework will be piloted in real healthcare settings in 5 major European hospitals and through an open piloting scheme with European DHT developers.

ASSESS DHT: Development & harmonisation of methodologies for assessing digital health technologies in Europe will increase the adoption of trustworthy and effective Digital Health Technologies across Europe with the aim to consolidate and streamline existing methods and tools for approval of innovative DHT and develop a new fit-for-purpose generic assessment framework, harmonised for Europe and aligned with the European Health Data Space (EHDS), but also catering for variability between settings, to respond to the methodological challenges with assessing DHTs, including their added value and health benefits for patients and the digital transformation of health systems.

Collaboration for Impact

In a collaborative effort, EDiHTA and ASSESS DHT are partnering to engage with key stakeholders within the European Health Ecosystem. This joint endeavour reflects a mutual dedication to enhancing the assessment of digital health technologies (DHTs) across Europe.

Through coordinated outreach and engagement strategies, both projects seek to raise awareness among decision-makers regarding the potential benefits of DHTs. They will adopt a unified approach in engaging relevant stakeholders, ensuring that a variety of perspectives and inputs inform the development and validation of their frameworks.

This collective initiative highlights the significance of stakeholder involvement in shaping the future of healthcare technology assessment. By pooling their resources, EDiHTA and ASSESS DHT aim to make a meaningful impact on the European HTA landscape, contributing to the sustainability and effectiveness of healthcare systems throughout Europe.

Get in touch:

EDiHTA

Project coordinators: Prof. Dario Sacchini and Prof. Americo Cicchetti (Università Cattolica del Sacro Cuore)

Website: www.edihta-project.eu

Contact: [email protected]

LinkedIn: EDiHTA-EU-project | X/Twitter: @EDiHTAProject

ASSESS DHT

Project coordinator: Dr. Veli Stroetmann (Empirica Communication and Technology Research)

Website: www.assess-dht.eu

Contact: https://assess-dht.eu/contact-us/

LinkedIn: ASSESS DHT | X/Twitter: @AssessDht

Questionnaire_assessing_digial_health_technologies.docx

Part 1 – Availability of frameworks/guidance documents/ guidelines to assess Digital Health Technologies (DHTs)
Question
Answer
Reference (link)
Does your agency use a classification/grouping system or a taxonomy to assign specific DHTs to groups/levels/tiers within the framework (guidance document/guideline) to determine specific assessment or evidence requirements/standards? If yes, please provide a reference/link and/or attach a copy of any unpublished document.

Does your agency have any frameworks/guidance documents/guidelines that are used for assessing DHTs in general or for specific groups of DHTs?

If yes, please briefly specify what document type it is and for which groups of DHTs and purpose the document is intended to use. If unpublished, please attach a copy of the document with your responses.
Document type:

Types/groups/tiers of DHT addressed:

Purpose of the document:

Does your agency have any published or unpublished documents on evidence requirements or submission guidelines/templates for DHTs? If yes, please provide a link or attach with your responses.

If no such document already exists: is your organization currently developing or adapting a framework (guidance document/guideline) to be used for assessing DHTs?

If no DHT-specific framework/guidance document/guideline is available, what frameworks/guidance documents/guidelines does your agency consider appropriate for use in Health Technology Assessment (HTA) of DHTs?

Part 2 – Currents status of assessed DHTs
Question
Answer
Reference (link)
Which digital health technologies have been evaluated by your agency so far?

Please provide us with a link where we can access these documents or send us the evaluation documents by e-mail.

Which digital health technologies are currently evaluated by your agency?

If possible, please provide us with a link to a listing of these technologies, or mention them directly.

Part 3 – Current gaps and weaknesses in assessing DHTs
Question
Answer
Reference (link)
Do you see any gaps and weaknesses in the methods available to HTA bodies for assessing DHTs?

How does your agency approach these challenges of assessing DHT?

Which possible future approaches to overcome challenges in assessing DHTs do you suggest?

Do different methods should be used at each stage of the lifecycle of a DHT? While we concentrate on the health technology assessment stage, there may be different methods for market access or post-marketing surveillance. Please shortly explain.

Does your agency already use different methodological requirements for an HTA depending on the life cycle?

Part 4 – Request for an expert specialized in AI
The Big Data Unit of the Andalusian public Progress and Health Foundation (Big Data-FPS) requests a nomination of an expert specialized in AI from your agency to participate in the following research.
Big Data-FPS will circulate questionnaire/s (as part of an online Delphi approach) to HTA experts specialized in AI. Questions included will pertain to the development of validation methods for AI-based decision support systems. The inquiries will focus on guidance for the validation of these systems, optimization of algorithms, and strategies for estimating predictive abilities using real-world data.
☐ Not-applicable: ’The scope of the questions is outside of our agency remit’
☐ Contact details: Name and e-mail address

EDiHTA-ASSESS_Presentation.pdf

EDiHTA + ASSESS DHT: The new EU-funded projects on a mission to revolutionise the European HTA landscape.

Rome, IT / Bonn, DE

EDiHTA and ASSESS DHT, the two projects recently funded under the Horizon Europe call HORIZON-HLTH-2023-IND-06-07 - Development and harmonisation of methodologies for assessing digital health technologies in Europe join forces to revolutionise the assessment of digital health technologies (DHTs) across Europe.

Digital health technologies (DHTs) are expected to improve healthcare quality and delivery across European countries, while also ensuring the long-term viability of Europe’s healthcare systems, but existing Health Technology Assessment (HTA) methodologies are unable to capture the real added value of DHTs. Both, EDiHTA and ASSESS DHT will address the methodological challenges of assessing DHTs, including their added value and health benefits for patients and the digital transformation of health systems.

EDiHTA: The first European Digital Health Technology Assessment framework co- created by all stakeholders in the European Health Ecosystem. EDiHTA will be the first flexible, inclusive, validated and ready-for- use European HTA framework reaching Technology Readiness Level (TRL) 6-7, allowing the assessment of different DHTs (e.g. telemedicine, mApps, AI) at different TRLs, territorial levels (national, regional and local) and perspectives (e.g. payer, society, hospital). All relevant stakeholders will contribute to its design, development and validation. The digital framework will be piloted in real healthcare settings in 5 major European hospitals and through an open piloting scheme with European DHT developers.

ASSESS DHT: Development & harmonisation of methodologies for assessing digital health technologies in Europe will increase the adoption of trustworthy and effective Digital Health Technologies across Europe with the aim to consolidate and streamline existing methods and tools for approval of innovative DHT and develop a new fit-for-purpose generic assessment framework, harmonised for Europe and aligned with the European Health Data Space (EHDS), but also catering for variability between settings, to respond to the methodological challenges with assessing DHTs, including their added value and health benefits for patients and the digital transformation of health systems.

Collaboration for Impact

In a collaborative effort, EDiHTA and ASSESS DHT are partnering to engage with key stakeholders within the European Health Ecosystem. This joint endeavour reflects a mutual dedication to enhancing the assessment of digital health technologies (DHTs) across Europe.

Through coordinated outreach and engagement strategies, both projects seek to raise awareness among decision-makers regarding the potential benefits of DHTs. They will adopt a unified approach in engaging relevant stakeholders, ensuring that a variety of perspectives and inputs inform the development and validation of their frameworks.

This collective initiative highlights the significance of stakeholder involvement in shaping the future of healthcare technology assessment. By pooling their resources, EDiHTA and ASSESS DHT aim to make a meaningful impact on the European HTA landscape, contributing to the sustainability and effectiveness of healthcare systems throughout Europe.

Get in touch:

EDiHTA

Project coordinators: Prof. Dario Sacchini and Prof. Americo Cicchetti (Università Cattolica del Sacro Cuore)

Website: www.edihta-project.eu

Contact: [email protected]

LinkedIn: EDiHTA-EU-project | X/Twitter: @EDiHTAProject

ASSESS DHT

Project coordinator: Dr. Veli Stroetmann (Empirica Communication and Technology Research)

Website: www.assess-dht.eu

Contact: https://assess-dht.eu/contact-us/

LinkedIn: ASSESS DHT | X/Twitter: @AssessDht

Questionnaire_assessing_digial_health_technologies.docx

Part 1 – Availability of frameworks/guidance documents/ guidelines to assess Digital Health Technologies (DHTs)
Question
Answer
Reference (link)
Does your agency use a classification/grouping system or a taxonomy to assign specific DHTs to groups/levels/tiers within the framework (guidance document/guideline) to determine specific assessment or evidence requirements/standards? If yes, please provide a reference/link and/or attach a copy of any unpublished document.

Does your agency have any frameworks/guidance documents/guidelines that are used for assessing DHTs in general or for specific groups of DHTs?

If yes, please briefly specify what document type it is and for which groups of DHTs and purpose the document is intended to use. If unpublished, please attach a copy of the document with your responses.
Document type:

Types/groups/tiers of DHT addressed:

Purpose of the document:

Does your agency have any published or unpublished documents on evidence requirements or submission guidelines/templates for DHTs? If yes, please provide a link or attach with your responses.

If no such document already exists: is your organization currently developing or adapting a framework (guidance document/guideline) to be used for assessing DHTs?

If no DHT-specific framework/guidance document/guideline is available, what frameworks/guidance documents/guidelines does your agency consider appropriate for use in Health Technology Assessment (HTA) of DHTs?

Part 2 – Currents status of assessed DHTs
Question
Answer
Reference (link)
Which digital health technologies have been evaluated by your agency so far?

Please provide us with a link where we can access these documents or send us the evaluation documents by e-mail.

Which digital health technologies are currently evaluated by your agency?

If possible, please provide us with a link to a listing of these technologies, or mention them directly.

Part 3 – Current gaps and weaknesses in assessing DHTs
Question
Answer
Reference (link)
Do you see any gaps and weaknesses in the methods available to HTA bodies for assessing DHTs?

How does your agency approach these challenges of assessing DHT?

Which possible future approaches to overcome challenges in assessing DHTs do you suggest?

Do different methods should be used at each stage of the lifecycle of a DHT? While we concentrate on the health technology assessment stage, there may be different methods for market access or post-marketing surveillance. Please shortly explain.

Does your agency already use different methodological requirements for an HTA depending on the life cycle?

Part 4 – Request for an expert specialized in AI
The Big Data Unit of the Andalusian public Progress and Health Foundation (Big Data-FPS) requests a nomination of an expert specialized in AI from your agency to participate in the following research.
Big Data-FPS will circulate questionnaire/s (as part of an online Delphi approach) to HTA experts specialized in AI. Questions included will pertain to the development of validation methods for AI-based decision support systems. The inquiries will focus on guidance for the validation of these systems, optimization of algorithms, and strategies for estimating predictive abilities using real-world data.
☐ Not-applicable: ’The scope of the questions is outside of our agency remit’
☐ Contact details: Name and e-mail address

Dokumendiregister	Sotsiaalministeerium
Viit	1.4-2/1617-1
Registreeritud	25.06.2024
Sünkroonitud	26.06.2024
Liik	Sissetulev kiri
Funktsioon	1.4 EL otsustusprotsess ja rahvusvaheline koostöö
Sari	1.4-2 Rahvusvahelise koostöö korraldamisega seotud kirjavahetus (Arhiiviväärtuslik)
Toimik	1.4-2/2024
Juurdepääsupiirang	Avalik
Juurdepääsupiirang
Adressaat	Technische Universität Berlin
Saabumis/saatmisviis	Technische Universität Berlin
Vastutaja	Triin Uusberg (Sotsiaalministeerium, Kantsleri vastutusvaldkond, Euroopa Liidu ja väliskoostöö osakond)
Originaal	Ava uues aknas

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