Reply to European Commission’s Roadmap on Health Data Space

Let the knowledge contained in data open doors to the future of healthcare

AESGP welcomes the European Commission’s Combined Evaluation Roadmap and Inception Impact Assessment on A European Health Data Space (EHDS), under the European Strategy for Data, and its ambition to introduce innovation, to take advantage of digital technology developments and to deliver concrete results to improve healthcare in Europe.

AESGP supports the social-economic and individual healthcare advantages of this initiative expected to increase cost-effectiveness for patients and healthcare systems by shortening time of diagnosis, optimising treatment options, avoiding duplication of tests and efforts, reducing medical errors, reducing inefficiencies in healthcare, facilitating personalised medicine, improving the effectiveness of prevention programmes, improving the monitoring of medicinal products and medical devices effectiveness and safety and facilitating epidemiological surveillance.

However, a Health Data Space should aim to be more person-centric and not circumscribe the European Commission’s assessment to professional, governmental or administrative views of healthcare. Only with patient generated data will the EHDS achieve an added value that proves successful. There is a pool of valuable data with impact on healthcare that is not currently structured – such as sleeping, nutritional and physical activity habits, as well as behavioural records and registration of transient symptoms or episodes – which could, under voluntary data submission, prove useful for personal care. There is data which already fails to be routinely captured in electronic health records, like non-prescription medicines’ and food supplements’ intake. In order to encourage and enable Real World Data research, these should be recorded in order to enable a more holistic view of what individuals take.

AESGP would like to highlight that, due to new technologies (wearables and other bio-sensors), the number of potential sources of data has increased. AESGP welcomes the Commission’s approach regarding the way to further regulate new technologies mentioned in its European Strategy for Data and agrees that there is a need for an agile approach. Individuals have an easily accessible overview of which data is collected where and can opt-out for specific purposes. Regulatory framework will require much quicker adaptation in the coming years so that people can have a timely benefit from digital progress. Technological acceleration needs to be paired with future-gazing regulation to ensure their on-time availability on the market without safety or security issues.

When it comes to self-care and healthcare, the authorized data usage for research purposes, for product improvement or for evaluation of personal needs is rather limited. While welcoming some of the initiatives already taken by the regulators, AESGP would like to call for more data applications to unleash the potential of this massive amount of data while guaranteeing the safety and security of European citizens.

Europe must ensure a fit for purpose regulatory framework so that people can safely enjoy the benefits brought by digital transformation and new technologies. AESGP believes that Industry, regulators, legislators and society at large have to work together to accelerate the effort if Europe is to become a leader in the digital health space.

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