Focus on patients

iRights.Lab and Bundesdruckerei Present Study on Electronic Health Records

On a recent parliamentary evening in the Deutscher Bundestag, a new study carried out by iRights.Lab in collaboration with the Bundesdruckerei (Federal Printing Company) was presented: “Zukunft Gesundheitsdaten –Wegweiser zu einer forschungskompatiblen elektronischen Patientenakte” (“The future of health data – towards research-compatible electronic health records”).

The study ben­e­fit­ed from the input of a range of per­spec­tives and exper­tise. The two lead authors, Ramak Molavi and Michael Kolain of the iRights.Lab team, were care­ful to take into account the lat­est devel­op­ments in this area. 

Sev­er­al key chal­lenges must be over­come if Ger­many is to be able to uti­lize the full poten­tial of dig­i­ti­za­tion in the field of eHealth. 

  • Secure, robust, easy-to-use infra­struc­ture: A com­pre­hen­sive and robust telem­at­ics infra­struc­ture must be estab­lished. This must be usable and easy to oper­ate for all par­ties involved. 
  • Patient sov­er­eign­ty: Health data stor­age is decen­tral­ized, and the patient can man­age access to their data autonomous­ly via a secure infra­struc­ture that acts on their behalf, and which pro­vides all nec­es­sary func­tions, such as iden­ti­fi­ca­tion and cer­ti­fied pseu­do­nymiza­tion or the pos­si­bil­i­ty of pass­ing on data to third par­ties for research pur­pos­es. This infra­struc­ture, referred to in this study as a “data trustee,” should be pro­vid­ed by the state free of charge.
  • Research com­pat­i­bil­i­ty: Health data holds great poten­tial for both the diag­no­sis and treat­ment of dis­eases. To ensure that its use and aggre­ga­tion does not con­flict with patients’ right to the spe­cial pro­tec­tion of their sen­si­tive data, the study relies on dis­trib­uted respon­si­bil­i­ties and places a spe­cial focus on the secu­ri­ty of the infra­struc­ture.
  • One pro­pos­al that emerges from the find­ings is that the data in elec­tron­ic health records can be made avail­able to research through a grad­u­at­ed process. A “trust cen­ter” would pro­vide for pseudonymization––in which it is made more dif­fi­cult to deter­mine the iden­ti­ty of the patient––or anonymization––in which re-iden­ti­fi­ca­tion of the patient is impos­si­ble. Anoth­er insti­tu­tion, the research data cen­tre, would then process this health data, which can then be secure­ly and anony­mous­ly trans­ferred to inde­pen­dent sci­en­tif­ic insti­tu­tions. Health data would thus always be stored in a decen­tral­ized and frag­ment­ed man­ner.
    In order to increase patients’ will­ing­ness to sup­port research by hand­ing over their health data, our study sug­gests that research insti­tu­tions should make their research results avail­able to the pub­lic, and espe­cial­ly to patients, in return, and pro­vide them in a com­pre­hen­si­ble, visu­al­ly pre­sent­ed form. The con­ver­gence of usabil­i­ty and research com­pat­i­bil­i­ty on the one hand and secu­ri­ty, robust­ness and data pro­tec­tion on the other hand is a core con­cern of the study.

For the entire study, the focus remains on the patients. The pro­tec­tion of health data and the patients’ abil­i­ty to use this data in a self-deter­mined man­ner must have top pri­or­i­ty. Oth­er­wise trust and thus the suc­cess of elec­tron­ic health records can­not be guar­an­teed.

With a robust telem­at­ics infra­struc­ture and an elec­tron­ic patient file man­aged by the insured, a trust­wor­thy dig­i­tal space for health data is cre­at­ed. Instead of the dif­fuse fear that patients’ pri­vate data will become freely acces­si­ble, we will uphold the model of a sov­er­eign and self-deter­mined patient. This is a patient who can take their health and con­va­les­cence into their own hands and man­age their health data from a pri­vate end device at their own dis­cre­tion. Such a patient can make the data from their elec­tron­ic health records avail­able to med­ical research with­out wor­ries and in return can receive tan­gi­ble ben­e­fits.” (Study: The future of health data)

Here you can down­load the entire study.

You can find the film of the event here.

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