The GMV-developed HARMONY, Big Data platform, an R&D project coming under the umbrella Innovative Medicines Initiative (IMI), has been presented at the 3rd Harmony General Assembly held in Valencia’s Hospital la Fé.

The first batch of data from one of the partners (data anonymization does not allow the donor to be known) has now been uploaded: i.e., data from more than 1400 people with acute myeloid leukemia and the results of the genetic analyses of 100 genes from cells of the sufferers, enabling disease-causing mutations to be determined in each one. The idea now is to progressively phase in more anonymized data and process it into evidence, building up to at least 100,000 data points from European patients with hematological malignancies.

In this first phase of the project GMV has designed the database to meet the requirements of all associate members (key agents in the clinical and academic fields, patients, healthcare technology assessment agencies, regulating agencies and the pharmaceutical industry) plus the platform capable of culling, standardizing and processing the data and the algorithms to convert this anonymous data into information that will help clinicians take the right decisions for applying personalized treatment: precision, evidence-based medicine.

Data Privacy
A sine qua non for all the various organizations uploading data to the platform – public institutions, national and European cooperative groups providing patient data and data from the clinical trials run by the pharmaceutical industry – is a cast-iron guarantee of patient privacy.

As pointed out by Doctor Guillermo Sanz, head of the Hematology Service of Valencia’s University and Polytechnic Hospital La Fe and co-leader of the project with Jesús María Hernández Rivas, specialist in clinical hematology and hemotherapy research and chair-holding professor at Salamanca University “the European General Data Protection Regulation has made the project much trickier. We have now had to make a special effort to obtain the consent of all 53 alliance partners, abiding not only by the Commission’s overarching legislation but the particular implementations in the national bodies of law of each participating member country”. Hernández Rivas goes on “as part of this endeavor, GMV, as manager of the project’s technological aspects, has input all the cybersecurity and anonymization tools to ensure GDPR-compliant data privacy”.

A Data Schengen
The Harmony (Healthcare Alliance for Resourceful Medicine Offensive against Neoplasms in Hematology) project, Europe’s biggest public-private hematology R&D initiative, has set several precedents in clinical and pharmaceutical research. Most notable is the fact that, for the first time ever, “we have managed to set up a joint platform with real, anonymized data of patients suffering hematological malignancies from, up to now, Germany, Spain, France, England and Italy” explains Hernández Rivas. It should be borne in mind here that, after the different national implementations of the General Data Protection Regulation (GDPR), “the free movement of data is not the same as the free movement of persons in the Schengen area”. All this, as the hematologist acknowledges, “has been possible thanks to the design of an agreed database and a data-culling and -processing platform that has quelled the privacy fears of all data-assigning organizations”.

John Butler, VP External Innovation & Alliances at Bayer takes up the story: “The platform, and GMV in particular, has made it possible not only to capture data donors but, even more importantly, to harmonize this data, analyze it and draw appropriate conclusions”. This calls for “not only a legal framework but also a technical base. This technical base has been provided by GMV. In GMV we have a partner working at the cutting-edge of healthcare information technology”.