The Health Data Use Act aims to improve access to health data for research and development in the pharmaceutical industry. The new regulation is also being taken advantage of by practice management system maker Medatix GmbH & Co. KG, which claims to collect anonymized treatment data from medical practices and make it available for scientific purposes.
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Participating practices using Medatix software receive a rebate of between 30 and 40 euros for providing patient data, depending on the number of doctors. This can make monthly fees for practice software cheaper by up to 28 percent. This was first reported by Medical News Service (AEND)Doctors must first ask for consent from their patients, Medatix said in response to the request. The software manufacturer provides text modules to inform patients.
Medatix Project “X.Panel”
for their project Medatixx launches “x.panel” projectAnonymized data is collected in a secure environment and sent to selected data recipients, with no trace to individual practices, doctors or patients. The Bundesdruckerei supports the project as a trust. Research partners include research-based drug manufacturers and scientific institutions.
The Medatix website says, “The anonymization concept complies with the legal framework of the General Data Protection Regulation (GDPR) and the German Federal Data Protection Act (BDSG). To ensure anonymity, the Bundesdruckerei GmbH is also used as a trust. Is.” The topic of anonymization is currently being discussed controversially, as the Hessian Data Protection Authority, which advised Medatixx on x.panel, knows.
“However, the process of anonymization requires a legal basis, as anonymization also involves data processing. However, legal bases can be routinely used for the purposes of scientific research, for example under federal Section 27 paragraph 1 of the Data Protection Act (BDSG), “the Hessian Commissioner for Data Protection and Freedom of Information (HBDI) said to haze online. Section 6 paragraph 3 sentence 3 of the Health Data Use Act therefore “explicitly allows data processing health facilities to anonymize stored health data in accordance with Art. 1 s 1 GDNG to third parties for the stated purposes”.
Data that Medatixx collects for the x.panel project.
(Image: Medatix)
“We have put various safety nets in place. The data is already anonymized locally in the practice software,” Medatics said in response to a request. To ensure anonymity, Mediatics seeks to use “individually defined boundaries” to ensure that no re-identification is possible even with background knowledge. A tool “developed specifically for research data by Berlin Charite” is used to check anonymity. It is also not possible to trace data related to individual practices. Mediatix did not want to provide further details or the anonymization concept that was finalized with HBDI for reasons of protecting trade secrets. When it comes to the methods used, Mediatex refers, among other things, to K-anonymity.
Uncertainties regarding subsequent use of data
Thilo Weichert, former data protection officer for Schleswig-Holstein, points out that it is still unclear to what extent service providers are allowed to continue using allegedly anonymized data of their customers. “The ECJ has always shown a very broad understanding of individual contexts. In the Breyer and IAB judgments, the ECJ emphasized the relevance of additional knowledge available. Such additional knowledge may be sufficiently confidential in medical treatment due to the large number of social It’s hard to keep context,” Weichert said. New data is regularly for sale on the darknet, which criminals can use to anonymize additional stolen data sets. According to Weichert, failed anonymization is particularly vulnerable if patients are not informed that their doctor is disclosing this sensitive data.
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