When asked about the issues around harnessing health data in Europe in Washington DC on October 27th, Prof Hans Georg Eichler, Senior Medical Officer of the European Medicines Agency responded, “I come from an area with hysterical data protection.”[1] Why would a regulator feel this way? Surely, Europe’s public health systems have access to health data that is second to none?

With a European system of nationalised health delivery and a population of over 400 million people, Europe should have at its disposal the greatest single collected searchable source of longitudinal health data available anywhere. By harnessing this information, Europe not only could reduce costs of treatment, optimise public health delivery, and provide better health to its citizens, but also revolutionise the way healthcare is managed and delivered by transforming the way evidence is gathered and evaluated for research in partnership with regulators.

However, with the overturn of the data sharing agreement by the European Courts of Justice called ‘safe harbour’ on October 6th, all bets have been off on the ability of data users, including Vital Transformation, to share data across boarders.

Confusion Reigns

The follow-up data sharing agreement being rushed through negotiations between the EU-US is called Privacy Shield, and it is mired in a sea of conflicting information. US Federal Trade Commissioner Julie Brill said Thursday the 4th of February; “My understanding is that [the European data authorities] are holding in abeyance enforcement actions while they undergo these evaluations.” [2]. However, this was followed by comments from Isabelle Falque-Pierrotin, chairwoman of the Article 29 Working Group handing the data negotiations for Europe, who said, “There is one thing that is for sure: If these companies are using the former Safe Harbor framework, it is illegal because this has been clearly invalidated by the judge.”[2]. This hardly adds confidence for those of us who use health data regularly in our work.    

With the cost of bringing a new therapy to market close to $3 bil[3], harnessing Europe’s available health data is a key to future efficiency gains and improved patient outcomes. Aside from the current geopolitical uncertainty, there are also increasing questions about EU data quality in general, and many national government’s ability to implement IT solutions.

The United Kingdom’s National Program for IT in the NHS (NPfIT) was the largest public sector IT programme ever attempted in the UK. Planned to unite all hospital, GP, medical, and nursing information, it was launched with great fanfare in 2002. However, marred by delays, stakeholder opposition and implementation issues, the programme was dismantled by the Conservative – Liberal Democrat Government in 2011, almost ten years after Prime Minister Tony Blair initiated it.[4] From an initial estimated budget of £6.2 billion[5], recent disclosures have put the final bill in excess of £20 billion (€25 Bil EUR), after the conclusion of paying off existing vendor contracts.

In May of 2015, a study was published examining the national records for the Danish National Prescription Registry (DNPR) for children that had received a prescription in the treatment of severe respiratory infection. It was found that a total of 207 children were reimbursed for the medication, but only 165 were also recorded in the DNPR. For 117 of those in the DNPR (71% of the number found), no registration of a prescription was in their record.[6] This is a huge data hole that could render outcomes research useless.

Vital Transformation is currently engaged in several research projects where we have required very fast access to large health datasets. Our last required 10 million patient records; we found there was no single one-stop-shop where we could obtain the data we needed quickly in Europe.

However, we were able to do so with our US data partners in three days. We’re now working with a client to re-purpose an existing therapy that could help 12,000 people a year in Europe and the US live a longer, healthier life.

And while the US situation is well known on the reuse of health data, what is lesser followed is the Chinese Government’s desire to move into Epidemiology, but do so for size.

Jianping Hu of the National health and family planning commission of the People’s Republic of China is implementing an IT reform process to establish a unified national healthcare system based on the international healthcare coding standard SNOMED CT.[7] The approach will be to link the data from the regional health information network to the data management systems in the provinces, and then deliver a full national dataset to the National Health Information System via the provincial health management networks. This would potentially represent a comprehensive centralised dataset of 1.2 billion patient records!

Where will healthcare research go if R&D can access one billion patient records in China?

Which brings us back to the EMIF conference on March 16 and 17th in Budapest. The Hungarian Government is reaching out to the IMI project, with the hopes of building a functioning real world data network in partnership with regulators, academics and practitioners. Europe must address the fact that the world does not live in a bubble, and there is global competition to capture the billions of Euros spent annually on healthcare R&D in the EU.

Perhaps it will be possible for visionary Central and Eastern European health ministers and administrators to bypass the entrenched politics of established nationalized healthcare systems and leapfrog to world class next-generation healthcare using robust healthcare data systems? Regardless, the increasing hostility to harnessing available healthcare data in Europe risks the EU falling behind in the international race to establish cutting edge R&D platforms and next generation treatment options.

In the final analysis, research investments will always flow along the path of least resistance.

EMIF’s programme in Budapest will discuss in depth harnessing electronic health records and real world evidence to create new therapies more efficiently. How do we maximize the benefits offered by harnessing available health data while solving issues around its reuse and work with regulators to provide the right evidence?

[1] https://twitter.com/DuaneSchulthess/status/659012901966102528

[2] http://www.ibtimes.com/safe-harbor-20-confusion-reigns-us-eu-send-mixed-messages-over-privacy-shield-data-2294215

[3] http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014_cost_study

[4] http://www.cl.cam.ac.uk/~rja14/Papers/npfit-mpp-2014-case-history.pdf

[5] http://www.telegraph.co.uk/news/uknews/1473927/Bill-for-hi-tech-NHS-soars-to-20-billion.html

[6] https://www.dovepress.com/the-danish-national-prescription-registry-in-studies-of-a-biological-p-peer-reviewed-fulltext-article-CLEP

[7] http://www.healthpolicyandtechnology.org/article/S2211-8837%2814%2900063-X/abstract