Hírek Our Feedback to EC 13 June 2022

Have your say - eHealth

You can also get involved in forming EU laws. The European Commission would like to hear your views on laws and policies currently in development. They offer a platform "Have your say" with the list of all new EU initiatives open for public consultation. You need to register to write your feedback.

https://ec.europa.eu/info/law/better-regulation/have-your-say

There are always 5 stages of each EU initiative, each stage is open for public consultation for a specific time frame:

  1. In preparation

  2. Call for evidence

  3. Public consultation

  4. Draft act

  5. Commission adoption

Digital health data and services – the European health data space

About this initiative: The European health data space will:

- promote safe exchange of patients’ data (including when they travel abroad) and citizens’ control over their health data

- support research on treatments, medicines, medical devices and outcomes

- encourage the access to and use of health data for research, policy-making and regulation, with a trusted governance framework and upholding data-protection rules

- support digital health services

- clarify the safety and liability of artificial intelligence in health.

Feedback period: for stage 5 it is 04 May 2022 - 28 July 2022

Link: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12663-Digital-health-data-and-services-the-European-health-data-space_en

Feedback from Europeans for Safe Connections

We "Europeans for Safe Connections" are against this initiative as a whole.

Personal data is digital gold. The bigger the dataset - the higher risk of the attack.

- 500 million Facebook user records were stolen in 2021
- 700 million LinkedIn users records were stolen in 2020-2021
- German insurance company Haftpflichtkasse was attacked in July 2021


Processing of personal medical data in a big centralised database is likely to result in a high risk to the fundamental rights and freedoms of individuals.
E.g. Workplace doctors can also reach these databases, so hiring selection will be upon health discrimination, even not revealed!

The Next Generation Internet initiative is designed to create an internet of humans. The European Commission has presented several legislative proposals as part of its digital and data strategies that will facilitate the use and sharing of (personal) data between more public and private parties. But according to the European Data Protection Board this will “significantly impact the protection of the fundamental rights to privacy and the protection of personal data”.

In our european citizens' initiative "Stop (((5G))) – Stay connected but protected" we are worried about medical data collected via wireless. But this eHealth initiative is far worse :(

We see networked medical devices and other mobile health technologies as a double-edged weapon. They have the potential to improve healthcare, but they can be a destructive tool that exposes patients and healthcare organizations to safety and health risks. Our concern is based on publicly known security incidents that undermine confidence in protecting citizens' health or life and medical data privacy of individual.

- 465,000 devices from Abbott’s were recalled by the US Food and Drug Administration (FDA), because Connected pacemakers were in 2017 implicated in a major hacking risk.
https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2017/8/abbott-recalls-465,000-pacemakers-for-cybersecurity-patch

- In March 2019, the U.S. Department of Homeland Security warned that “low skill level” computer hackers through the Bluetooth can easily gain access to some implanted connected pacemakers, manipulate with it and endanger patient´s life.
https://cdn.stmarytx.edu/wp-content/uploads/2020/10/Study-of-Wireless-Security-Attacks-on-Medical-Devices.pdf

- Researchers were able to overtake control of some wireless insulin pumps and glucose monitoring systems.
https://cdn.stmarytx.edu/wp-content/uploads/2020/10/Study-of-Wireless-Security-Attacks-on-Medical-Devices.pdf


Read our ECI proposal here:
https://signstop5g.eu/en/solutions/protection-of-our-data/proposal-19

Best regards
Petra Bertová
on behalf of Europeans for Safe Connections

https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12663-Digital-health-data-and-services-the-European-health-data-space/F3293852_en

eHealth feedback
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