Table of Contents Table of Contents
Previous Page  111 / 280 Next Page
Information
Show Menu
Previous Page 111 / 280 Next Page
Page Background

She added that during the rest of 2015, “the council will address the ethical

and other normative issues raised by Big Data developments in the health

sector in internal deliberations”, and that she hopes that such efforts will

“eventually result in the publication of an opinion document” during 2016.

Brussels’ role

According to the European Commission’s ‘eHealth Action Plan 2012-

2020’, key steps need to be taken to realise the full benefits of big

healthcare data. The communication states that both e-health and

wellbeing ‘are areas with high growth potential’ alongside ‘possibilities

for innovation, notably by unlocking effective health data exchange’.

The document cites the ‘lack of legal clarity for health and wellbeing

mobile applications and the lack of transparency regarding the

utilisation of data collected by such applications’ as barriers to realising

e-health deployment. Furthermore, the ‘interoperability of ICT-enabled

solutions and of data exchange’ is seen as the ‘precondition for better

co-ordination and integration across the entire chain of healthcare

delivery and health data exchange’. Such actions, the Commission

says, will help realise the EU e-health single market. In addition, Horizon

2020 is backing ‘innovative instruments, tools and methods for

unlocking the value of data and for advanced analytics, diagnostics

and decision making’.

Balancing ethics and the research potential of big healthcare data is a

narrow needle to thread. As the German Ethics Council forms its views

on the use of big health data, the Commission is already considering the

wide-ranging implications.

legal challenges that these developments pose.

Our annual meeting examined these issues

from several perspectives, considering, for

example, technological, theoretical, societal,

ethical and legal viewpoints and aspects.”

According to Schultz, there are three areas that

are “particularly interesting and potentially

problematic developments” in big health data

which the German Ethics Council wishes to

assess, namely the impact of wearables,

medical research, and the analysis of data.

“Firstly, increasing opportunities to engage in

‘self-tracking’ or ‘life logging’ using wearable

devices and apps that record parameters such

as physical activity, sleep patterns, pulse or

emotion promise a better understanding of how

the environment and our own behaviour may

affect our health and wellbeing. However,

without user-friendly and transparent rules for

storing, sharing and interpreting such data, this

trend also harbours risks that third parties such

as employers or insurers might create pressure

to access and use such information with

potentially detrimental effects to those who

collect it or wish to opt out.

“Secondly, medical research also increasingly

uses big datasets. These come from very

disparate sources, for example large molecular

datasets from sequencing projects or brain

scans, and are sometimes pooled in even

bigger datasets in large biobanks. Even data

collected by the aforementioned wearables and

apps is finding its way into research projects.

“Challenges here range from finding ways to

draw valid conclusions from such large and

disparate datasets to adapting consent

procedures and protecting participants’

privacy in the face of ‘open data’ trends and

increasing possibilities to re-identify even

anonymised data.

“Thirdly, as digital collection and analysis of

large and diverse datasets also become more

common in daily medical practice, we must ask

how this may affect patient privacy and patient-

doctor relations.”

Expanding her thoughts, Schultz said, “The

German Ethics Council has only recently begun

its work on the topic of Big Data”, though “the

discussions during the annual meeting have

confirmed the importance of the topic to the

German Ethics Council”.

Dr Nora Schultz

German Ethics Council

B R OW S E

www.ethikrat.org

H O R I Z O N

2 0 2 0

www.horizon2020projects.com

H O R I Z O N 2 0 2 0 P R O J E C T S : P O R TA L

I S S U E S E V E N

111

H E A L T H & P AT I E N T D ATA

According to the

council, big health

data could lead to

changes in the

relationship between

patients and doctors