Funded byGZ 10.470/0016-II/3/2013

ISC Seminar Impact of GDPR

Dublin, March 2nd, 2017

Kurt Zatloukal, MUG Graz Austria

Data in Medical R&D and Health Care:

Impact of the GDPR

Data Will Transform Medicine

• Personalized medicine requires detailed description of diseases

• Linking environment – genetics – health

• Big data:

Volume: genetic, imaging (radiology, digital pathology)

Complexity: free text, many different data types, time courses

Data analytics: computing power, algorithms

• Societal expectations and challenges: ELSI

• Economic implications

Which Types of Data?

Electronic health recordsPrescription dataDisease registriesClinical trial dataEpidemiological data-omics dataImaging dataBiosensorsBiobanksResearch dataHealth AppsSocial mediamany more ……..

06.03.2017 3

~ 0.1 PB data per patient/ lifetime

European General Data

Protection Regulation

The Regulation shall apply from May 25th 2018

GDPR: A Response to

Public Concerns

GDPR:To enable the

European Single Digital Market Strategy

GDPR: Key changes

• Empowerment of data owner

• Adequacy of data protection in third countries

• A common European basis; details to bespecified by Member States and in Code ofConducts

• Severe penalties (up to 20 Million € or 4% ofglobal turnover)

Source: European Commission - press release, December 15th 2015

GDPR and Data Owner

Empowerment

• Information on processing of personal data

• Easier access to your own data

• A right to data portability

• A clarified right to be forgotten

Source: European Commission - press release, December 15th 2015

Implementation Challenges

Many practical issues not yet specified

Risk of fragmentation at MS level

No „grandfather“ clause

Major technical and manegerial actionsrequired

May 25th 2018 is comming soon!

Thank You for Your Attention