EU Plans Cross-Border Health Data Exchanges
Created at 29.December 2020, 19:00 | Category: News
EU aims for broader sharing and analysis of health outcomes, greater flexibility when traveling
The European Commission and EU member state governments are proposing new rules to promote better exchange and access to different types of health data including electronic health records, genomics data and data from patient registries. The plan aims to support healthcare delivery using primary use of data, but would also support health research and health policy making purposes via the use of so-called secondary use of data, according to an outline of the plan on the European Commission’s website.
Under the plan, public health systems in the EU’s 27 member countries would be encouraged to collect data in a standardized format. A core part of the plan known as the Data Governance Act would establish a horizontal framework for the use and reuse of sensitive and valuable data in areas such as health. To that end, the plan would allow access to health data “under a trusted governance and clear rules and support the free movement of digital health services,” Stella Kyriakides, Commissioner for Health and Food Safety, said in a statement. By 2025, patients from all Member States should be able to share their data with healthcare professionals of their choice when traveling abroad.
One of the driving impulses for regulation was the COVID pandemic, Commissioner for Internal Market Thierry Breton said in a statement. “Strengthening and extending the use and re-use of health data is critical for an innovative and competitive EU healthcare sector, and will help make Europe more resilient to weather challenges such as the current pandemic,” Breton said.
According to a draft proposal of the regulation, the EU aims to create a legal framework within which the Union can react rapidly and trigger the implementation of preparedness and response measures to cross-border threats to health across the EU in the form of a Regulation.
“The COVID-19 pandemic has shown that the EU’s mechanisms for managing health threats suffer from general shortcomings that require a more structured Union-level approach if we are to deal better with future health crises,” the EU proposal said. “Since the start of the outbreak, multiple discussions have taken place with Member States including at health ministers’ level, have seen calls for a more consistent and coordinated approach to preparing for and managing health crises in the EU.”
Last spring, EU governments began collaborating to create COVID-tracking apps that work seamlessly in Germany, Ireland, and Italy. Some 30 million people have downloaded the apps, the EU said in a statement. The Czech Republic, Denmark, Latvia, and Spain later joined the program, which was setup by T-Systems and SAP, and operated from the EU Commission’s data center in Luxembourg.
This was seen as a first step in making health information available for Europeans living or traveling outside their home borders. Ultimately, the goal is to enable the exchange of the electronic patient record summaries and electronic prescriptions by 2022 between the 27 member states under the eHealth Digital Service Infrastructure (eHDSI).
Some EU countries are already moving forward with cross-border healthcare cooperation. By the end of 2020, Finland, Estonia, Portugal, and Croatia will be able to exchange imaging data, laboratory results, and discharge reports to facilitate remote consultations, according to a report by the Finnish Innovation Fund Sitra.
But privacy concerns abound. Rights groups say citizens must be able to “opt-in” to the medical data sharing schemes and that any plan must adhere to the General Data Protection Regulation (GDPR).
EU to collect 10 million genomes
An additional part of the plan, known as the Pharmaceutical Strategy for Europe, would establish “the secure federated access to 10 million genomes across borders for research, innovation and clinical applications, including personalized medicine 2025”.
The genetic data might help prevent cancer and other non-communicable diseases like heart attacks, stroke, chronic respiratory diseases, and diabetes, according to an analysis by The Finnish Innovation Fund Sitra. The plan builds on work begun as part of the “European ‘1+ Million Genomes’ Initiative”.
In order to encourage EU countries to adopt the program, Europe’s pharmaceutical lobby, EFPIA, suggested in a policy paper that the European Commission (EC) and Members States “should consider providing a mix of financial and non-financial incentives for data holders to share their data, both with public and private market participants. Such incentives could potentially include traceability of the data, financial rewards/tokenization, reciprocity in access to data, giving credit to data providers, and curators in publications that are based on the data, as well as IP-based incentives.”
Industry wants to encourage data sharing
Public acceptance will be key to the success of the EU’s health plans. But some have voiced criticism of pharmaceutical industry lobbying attempts to equate sharing medical data with donating blood.
“Data altruism is a misleading concept which can lead to malpractice,” European consumer rights group BEUC wrote in a position paper. “If patients and consumers were to provide access to their data for health research under a public purpose research initiative, this should not be for commercial purposes.”
Pharma executives have flagged what they call “data parochialism” as a possible roadblock to gaining access to data. To create public acceptance, many in the industry have likened data sharing to blood donations – despite the fact, unlike donating blood, much of the public health data could end up in the hands of private corporations.
“Think for example about how people give blood or donate organs to help those whom they don’t know,” Padriac Ward of Roche told a panel in November. “That’s the same spirit we should foster around data.”
Pressure is also coming from European tech startups, whose executives say citizen data protections like the General Data Protection Regulation (GDPR) put European health-tech companies at a disadvantage compared to their counterparts in the U.S. and China.
“While digital health startups are highly innovative and adaptable actors which seek to be compliant from day one, they are also smaller economic players,” Brussels-based trade group Allied For Startups said in a statement. “Navigating complex regulations, such as GDPR, the Medical Device Regulation and upcoming rules on Artificial Intelligence require additional resources which could otherwise be directed towards innovation.”
Much as happened with EU rules that eliminated cell phone roaming fees for travel within Europe, the proposed plan could reducing costs by making duplicate tests unnecessary.