{"id":7927,"date":"2024-06-25T16:42:17","date_gmt":"2024-06-25T15:42:17","guid":{"rendered":"https:\/\/esc-info.eu\/?p=7927"},"modified":"2026-02-06T07:42:57","modified_gmt":"2026-02-06T06:42:57","slug":"have-your-say-health-technology-assessment","status":"publish","type":"post","link":"https:\/\/esc-info.eu\/da\/have-your-say-health-technology-assessment\/","title":{"rendered":"Have your say \u2013 Health technology assessment"},"content":{"rendered":"\n

You can also get involved in forming EU laws. The European Commission offers a platform \u201cHave your say\u201d with the list of all new EU initiatives open for public consultation. You need to register to write your feedback: ec.europa.eu\/info\/law\/better-regulation\/have-your-say<\/a><\/p>\n\n\n\n

This article contains 2 initiatives (see below)<\/p>\n\n\n\n

Health technology assessment \u2013 joint clinical assessments of medical devices<\/h2>\n\n\n\n

About this initiative:<\/strong>This initiative concerns joint clinical assessments of medical devices and in vitro diagnostic medical devices. It sets out implementing rules to ensure that EU-level assessments are conducted in good time and that the relevant experts are involved or consulted.<\/p>\n\n\n\n

Feedback period:<\/strong> for stage 4 it is 28 May 2025 – 25 June 2025<\/p>\n\n\n\n

Link:<\/strong> https:\/\/ec.europa.eu\/info\/law\/better-regulation\/have-your-say\/initiatives\/13707-Health-technology-assessment-joint-clinical-assessments-of-medical-devices_en<\/a><\/p>\n\n\n\n

Feedback from Europeans for Safe Connections<\/h2>\n\n\n\n

The proposed REGULATION (EU) and its ANNEXES do not specify technical requirements for data transmission from medical devices to IT infrastructure, such as mandating Wi-Fi or other particular communication protocols. Nevertheless, this framework necessitates that information concerning the characteristics and usage of medical devices, including those with connectivity features, be integral to the assessment process. <\/p>\n\n\n\n

Key aspects of this process include: <\/p>\n\n\n\n

Dossier Submission by Health Technology Developers (HTDs):<\/strong> HTDs are required to submit comprehensive dossiers. Assessment Scope Development: The scope of the health technology assessment (HTA) is defined. <\/p>\n\n\n\n

Joint Clinical Assessment Report:<\/strong> This report details the medical device’s characteristics, reflecting the information provided in the dossier. It specifically includes a “description of the connected technology” and details on AI\/machine learning features, where applicable. <\/p>\n\n\n\n

Consultation with Experts and Stakeholders: <\/strong>Stakeholder groups, such as patient organizations (e.g., E.S.C.), should be afforded the opportunity to provide input on the medical device, particularly to evaluate health considerations related to its wireless connectivity. E.S.C. provided the HTA with a list of technical specifications in December 2024 and March 2025 for measuring and evaluating non-ionizing radiation (NIR), encompassing both extremely low frequency (ELF) waves and radiofrequencies. Regarding the identification of patient experts for joint working meetings, ESC has confirmed its capacity to nominate scientific experts (e.g., medical doctors, biochemists) qualified to assess the risks of electromagnetic field (EMF) exposure from new devices for: a) The general population b) Electrohypersensitive (EHS) individuals. <\/p>\n\n\n\n

In summary, while the documents currently under public consultation lack specific guidelines on the use of wireless connectivity, they establish a process within the EU HTA framework where information on connected technology in medical devices is explicitly required and systematically assessed. The strategy for addressing device connectivity within this framework involves the submission of detailed information in the dossier, engagement with experts and stakeholders during consultations, and the potential use of the Joint Scientific Consultation (JSC) mechanism for guidance on evidence generation.<\/p>\n\n\n\n

Health technology assessment \u2013 procedural rules for assessing and managing conflicts of interest<\/h2>\n\n\n\n

About this initiative: <\/strong>This initiative concerns the management of conflicts of interest in the clinical assessment of new health technologies. It sets out implementing rules to ensure that EU-level assessments of new health technologies are conducted in an independent and impartial manner, free from conflict of interest.<\/p>\n\n\n\n

Feedback period:<\/strong> for stage 4 it is 29 May 2024 – 26 June 2024<\/p>\n\n\n\n

Link:<\/strong> https:\/\/ec.europa.eu\/info\/law\/better-regulation\/have-your-say\/initiatives\/13751-Health-technology-assessment-procedural-rules-for-assessing-and-managing-conflicts-of-interest_en<\/a><\/p>\n\n\n\n

Feedback from Europeans for Safe Connections<\/h2>\n\n\n\n

We, “Europeans for Safe Connections<\/em>“, fully support managing conflicts of interest within the joint work of the Member State Coordination Group on Health Technology Assessment.<\/p>\n\n\n\n

We believe that not only new health technologies should be assessed but also existing health technologies should be assessed based on new data evidence. For example there is a new Dr. Panagopoulos study related to gamma radiation treatment. He discovered that mobile telephony electromagnetic fields significantly enhanced the genotoxic action of gamma radiation thus people should be aware of the increased risk during treatment periods. https:\/\/esc-info.eu\/wp-content\/uploads\/2024\/06\/Panagopoulos-MobphoneandgammaradiationHPBLs-2024.pdf<\/a><\/p>\n\n\n\n

Furthermore, we highlight the global implementation of fifth-generation (5G) radiofrequency (RF) radiation without adequate investigation into its potential risks to human health and the environment. This situation has sparked debates among concerned individuals across various countries.<\/p>\n\n\n\n

In September 2017, an appeal was made to the European Union (EU) by over 390 scientists and medical doctors. They requested a moratorium on 5G deployment until thorough scientific evaluations of potential negative consequences could be conducted. However, recent publications from the International Commission on Non-Ionizing Radiation Protection (ICNIRP), which is tied to EU and government expert groups, have raised concerns. Conflicts of interest and industry affiliations may have influenced biased reports.<\/p>\n\n\n\n

The lack of unbiased risk assessment for 5G technology poses risks to populations. Additionally, there appears to be a group monopolizing evaluation committees, reinforcing a no-risk paradigm. We believe that such behavior qualifies as scientific misconduct, as it impacts people\u2019s lives.<\/p>\n\n\n\n

We quote the European Parliamentary Research Service document: “Various studies suggest that 5G would affect the health of humans, plants, animals, insects, and microbes \u2013 and as 5G is an untested technology, a cautious approach would be prudent<\/em>.<\/em><\/p>\n\n\n\n

Hundreds of recent scientific studies, including peer-reviewed research, and even rigorously peer-reviewed research demonstrating serious long-term adverse effects on human health from recent and earlier generations of wireless technologies.<\/p>\n\n\n\n

Therefore we suggest to appoint new ethics committee or expand EGE’s activities (EGE – The European Group on Ethics in Science and New Technologies, whose role is defined by Article 2 of Commission Decision 2016\/835<\/a>). We call for the creation of a body that brings together scientists and representatives of different schools of thought, elected in complete independence from business circles and governments. This body would be responsible for creating the conditions for a public debate before any major technology is introduced, and for preparing decisions to be validated by referendum.
Read more: https:\/\/signstop5g.eu\/en\/solutions\/protection-of-our-data\/proposal-23<\/a><\/p>\n\n\n\n

At the same time, the public is not told that hundreds of independent scientific studies, including peer-reviewed research, and even rigorously peer-reviewed research, demonstrate serious long-term effects on human health from new and earlier generations of wireless technologies on, for example, fertility, the nervous system, the cardiovascular system, and cellular processes.<\/p>\n\n\n\n

<\/a> \u201dThe UN Universal Declaration of Human Rights<\/a>, the Helsinki Accords<\/a> and other international treaties recognise that informed consent prior to interventions that might affect human health is an essential, fundamental human right, which becomes even more controversial when considering children’s and young people’s exposure\u201d<\/em> quoting a statement from a European Parliamentary Research Service document (Effects of 5G wireless communication on human health).<\/p>\n\n\n\n

Best regards
Europeans for Safe Connections<\/strong>
This feedback was sent from a wired internet connection
\u2013 No use of harmful radiation
\u2013 Less electricity consumption
\u2013 Increased data security<\/em><\/p>\n\n\n\n

Link to our feedback: https:\/\/ec.europa.eu\/info\/law\/better-regulation\/have-your-say\/initiatives\/13751-Health-technology-assessment-procedural-rules-for-assessing-and-managing-conflicts-of-interest\/F3470200_en<\/a><\/p>\n\n\n\n

Facebook post available for sharing: https:\/\/www.facebook.com\/share\/p\/qZneciaXCaLv7kje\/<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

We believe that not only new health technologies should be assessed but also existing health technologies should be assessed based on new data evidence.<\/p>\n","protected":false},"author":2,"featured_media":7928,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_links_to":"","_links_to_target":""},"categories":[136],"tags":[],"class_list":["post-7927","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-have-your-say"],"yoast_head":"\nHave your say \u2013 Health technology assessment<\/title>\n<meta name=\"description\" content=\"We believe that not only new health technologies should be assessed but also existing health technologies should be assessed based on new data evidence.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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