The new EU health data space is coming and industry wants it

The new EU health data space is coming and industry wants it

This article is the product of a POLITICO working group, presented by Janssen.

Everyone wants a seat at the table in the European Health Data Area. But will there be room for industry?

This is the question companies face as they try to convince the Parliament, the Council and the Commission that they can be trusted to play an important role in the creation and deployment of the Data Space of health.

As the Commission’s proposal, first presented in May, is reworked into what will be the final regulation, the question is to what extent private companies will have access to some of the world’s most valuable data. block.

Industry wants, but not without promises, that its own research and intellectual property will be protected. On the other side of the table are privacy organizations like the European Data Protection Board and worried academics who fear the proposal could open the door to abuse of health data or privacy breaches.

With companies being fined for health data breaches and growing concerns over Big Tech’s access to patient health information, it may be difficult to convince MPs from the two parliamentary committees who have been assigned the file to grant the industry the level of access that it wishes.

The dossier is shared by the Committee on the Environment, Public Health and Food Safety (ENVI) as well as by 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 there is already something happening for the private sector – an unusual show of solidarity from groups that are often not aligned. In a joint statement Oct. 20, more than two dozen research and health professional organizations, patient groups and industry associations made several key demands for the health data space. That’s not to say the groups are aligned on all aspects of industry participation, but it’s a promising sign of unity of purpose as negotiations get underway.

Industry pitch

Industry should benefit from the health data space, with the Commission proposal stating that the use of health data for research should allow public and private entities to use the data for research and innovation. The only clearly prohibited areas are if the use of the data harms people, increases people’s insurance premiums, is used to advertise to people or develop harmful products.

The devil is, as always, in the details. Questions remain regarding contentious issues such as the use of pseudonymised data, applicable fees for data access and, importantly, whether industry will be involved in the governance of the Health Data Space.

For its part, the industry – which includes organizations such as pharmaceutical companies and private healthcare providers – hopes that by demonstrating the value it can bring, Brussels bureaucrats, diplomats and MPs will be convinced.

“Can using health data for R&D lead to increased profit margins? Of course, and this is necessary to overcome investment risk,” said Ray Pinto, director of digital transformation policy at tech industry group DIGITALEUROPE, speaking at a POLITICO task force on the space of health data in October. But Pinto notes that the industry will also be able to take these huge datasets and create quality data from them, using them to strengthen things like cybersecurity or to make a doctor’s life easier.

For Angel Martín, Senior Director of Digital Health Promotion at Janssen for EMEA, the purposes for which the data is used and the potential social benefits are key.

“If we believe that industry, within these objectives, can bring benefits to society, I don’t see why we would exclude part of the innovation,” he said. What Martín stresses that it will take principles on how data is shared and used by all actors, which will be key to building trust.

It’s good to share

The idea that patients are always against sharing data with industry also doesn’t ring true for those who have worked in healthcare for years.

“When you interact with patients or members of the public and really explain the value of health data, they understand pretty quickly…that it’s the purpose that matters, that it’s the organization that is undertaking the research…. is a public body or a private body is not the most important thing, as long as they follow good trust practices,” said Dipak Kalra, President of the European Institute for Data Innovation of health. “What matters most is the goal.”

The challenge is to get the whole population of the EU to let go of the idea that “industry is not to be trusted”, Kalra said.

Even then, the industry is sure to come up against finicky privacy regulators.

Already, the European Data Protection Board and the EU’s internal privacy regulator, the European Data Protection Supervisor, have issued a response that aims to curb some of the ambitions of the original proposal. . Regulators say wellness apps and other digital health apps shouldn’t be made available for secondary use and that storage of sensitive health data should only take place in Europe. These are two issues that the industry will likely push back.

The private sector is not just concerned about its ability to be part of the health data space – it is also concerned about how the data it contributes to the space will be used by others. . The European Federation of Pharmaceutical Industries and Associations has previously stated that the Health Data Space “must provide clearer assurances on the terms of data sharing, including how intellectual property and trade secrets will be protected when data will be requested” from a pharmaceutical company.

Registration on the guest list

One of the industry’s first goals is to have a say in how the health data space is managed, and to do that, it needs to be part of the board that will oversee the health data space. ‘effort. The industry is quick to insist that it’s not asking for a “free-for-all”. “were talking [about a] very specific interaction,” Pinto said.

This interaction will need to be very clearly delineated, Markus Kalliola, coordinator of the TEHDAS project – a joint initiative to ensure safe access to data in a way that serves the cause of public health. He cautioned against allowing the same people who make the rules to benefit from these edicts. In fact, ensuring that this doesn’t happen would actually benefit the industry, Kalliola said.

The joint consensus statement released on October 20 does not specifically mention the board, but makes it clear that top of the wish list is for everyone – including industry – to be “strongly involved” in the health data space. “Gaining trust and broad engagement will be essential for the general acceptance, effectiveness, endorsement, and rapid adoption of EHDS,” they write.

It remains to be seen whether the industry can first gain the trust of MEPs, Commission officials and diplomats negotiating the proposal.

This article is part of POLITICO’s Evolution of Healthcare series presented by Janssen. It is the product of a working group and was produced with complete editorial independence by POLITICO reporters and editors. Learn more about editorial content presented by external advertisers.

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