Everyone wants a seat at the European Health Data Table. But will there be room for industry?
This is the question companies face as they try to convince Parliament, the Council and the Commission that they can be trusted to be an important player in creating and deploying the health data space.
as a commission suggestionwhich was first introduced in May, to what will constitute the final regulation, and the looming question is how much private companies will have access to some of the most valuable data in the block.
The industry wants it, but not without promises to protect its research and intellectual property. On the other side of the scale are privacy organizations such as the European Data Protection Council and concerned academics who fear the proposal could open the door to health data abuse or privacy breaches.
With the presence of companies fined health data breaches and their escalation interest On the access of big tech companies to health information about patients, and persuading MEPs via the two parliamentary committees the dossier is dedicated to allowing the industry the level of access they want, can be difficult.
The file is shared by the Committee on Environment, Public Health and Food Safety (ENVI) as well as the Committee on Civil Liberties, Justice and Home Affairs (LIBE). Tomislav Sokol, MEP from the European People’s Party group, will be rapporteur for ENVI, while Annalisa Tardino, from the Identity and Democracy group, will be rapporteur for LIBE.
But one thing is really going for the private sector – an extraordinary display of solidarity from often unbiased groups. in joint statement On October 20, more than two dozen medical and research organizations, patient groups, and industry associations submitted several key questions regarding the health data space. This does not mean that the groups align with all aspects of industry involvement, but it is a promising sign of unity of purpose as negotiations begin.
The stadium in the industry
The industry will benefit from the health data space, with the commission suggestion It states that the use of health data for research should enable both public and private entities to use the data for research and innovation. The only obvious areas that are prohibited are whether the use of data will harm people, increase people’s insurance premiums, be used to advertise to people or to develop harmful products.
The devil is as always in the details. Questions remain about contentious issues such as the use of aliased data, fees applicable to data access, and most importantly, whether the industry will be involved in managing the health data space.
For its part, the industry – which includes organizations such as drug companies and private healthcare providers – hopes that by demonstrating the value they can provide, Brussels bureaucrats, diplomats and MEPs will be convinced.
Can using health data for research and development increase profit margins? “Certainly this is necessary to overcome investment risk,” said Ray Pinto, director of digital transformation policy at technology industry group DIGITALEUROPE, speaking at the POLITICO working group in the health data space in October. But Pinto points out that the industry will also be able to take these huge data sets and create high-quality data from them, and use them to enhance things like cybersecurity or to make a doctor’s life easier.
For Angel Martín, Janssen’s Senior Director of Digital Health Advocacy for EMEA, the purposes for which the data is used and the potential social benefits are key.
“If we think that, within these purposes, industry can benefit society, I see no reason to exclude some of the innovation that is taking place,” he said. what or what Martin stresses that principles will be needed on how data is shared and used by all players, which will be key to building trust.
It’s good to share
The idea that patients are always against sharing data with the industry also doesn’t hold true for those who have worked in the health sector for years.
“When you engage with patients or members of the public, and really explain the value of health data, they understand very quickly… that the target is what matters, whether it’s the body doing the research….” said Deepak Kalra, president of the European Institute for Innovation through Health Data, “ A public body or a private body is not the most important thing, provided they stick to good trust practices.” “What matters is the purpose.”
The challenge, Kalra said, is getting EU residents to shift away from the idea that “the industry is not trustworthy”.
And even then, the industry is sure to face tough privacy regulators.
Already, the European Data Protection Council, the European Union’s internal privacy regulator, and the European Data Protection Supervisor have issued a statement Response which seeks to curb some of the ambitions of the original proposal. Regulators say wellness and other digital health apps should be excluded from making them available for secondary use and that sensitive health data should only be stored in Europe. Both are issues the industry is likely to push against.
The private sector also doesn’t care about its ability to be part of the health data space – it’s also concerned about how the data it makes up for the space is used by others. The European Federation of Pharmaceutical Industries and Associations already have He said That the health data space “must make clearer assurances about terms of data sharing, including how intellectual property and trade secrets are protected when data is requested” from a pharmaceutical company.
Get guest list
One of the industry’s first goals is to have a say in how the health data space is run, and to do that you need to be part of the board that will oversee the effort. The sector is quick to stress that it’s not asking for “free for all”. “They were talking [about a] “A very specific interaction,” Pinto said.
This interaction must be very clearly defined, Marcus Caliola, Project Coordinator for TEHDAS – a joint initiative to ensure secure access to data in a way that serves the cause of public health. He warned against allowing the same people who set the rules to benefit from those decrees. Ensuring this does not happen will actually benefit the industry, Caliola said.
The Joint Consensus Statement published on October 20 does not specifically mention the board of directors, but it does make clear that the top of the wish list is for everyone – including the industry – to be “strongly engaged” in the health data space. “Gaining trust and broad participation will be essential to the general acceptance, efficacy, endorsement and rapid adoption of EHDS,” they wrote.
What remains is whether the industry can first earn the trust of the MEPs, Commission officials and diplomats negotiating the proposal.
This article is part of Politico Healthcare Evolution Serial presented by Janssen. It is a product of Team It has been produced with complete editorial independence by Politico’s reporters and editors. learn more About editorial content provided by external advertisers.