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The European Medicines Agency ("EMA") recently set up
a task force, along with the national competent
authorities in the EEA, to analyze how medicines regulators in the
EEA can use big data to better develop medicines for humans and
animals. This follows a workshop in November last year to identify
opportunities for big data in medicines development and regulation,
and to address the challenges of their exploitation. "Big
data" in the healthcare sector is the sum of many parts, which
include the records of a multitude of patients, clinical trial
data, adverse reaction reports, social media commentary and app
records. Several projects have been set up across the EU to
aggregate and analyze such data, which are explored by the European
Commission in its December 2016 Study on Big Data in Public Health,
Telemedicine and Healthcare. The EMA has recognized that
"the vast volume of data has the potential to contribute
significantly to the way the benefits and risks of medicines are
assessed over their entire lifecycle."
So who will make up the new EMA task force and what are its
objectives?
The task force comprises staff from several medicine regulatory
agencies in the EEA and will be chaired by the Danish Medicines
Agency. It's first actions will be carried out over the next 18
months and they include:
Mapping sources and characteristics
of big data.
Exploring the potential applicability
and impact of big data on medicines regulation.
Developing recommendations on
necessary changes to legislation, regulatory guidelines or data
security provisions.
Creating a roadmap for the
development of big data capabilities for the evaluation of
applications for marketing authorizations or clinical trials in the
national competent authorities.
Collaborating with other regulatory
authorities and partners outside the EEA to consider their insights
on big data initiatives. News of the task force comes on the back
of the update that the UK data protection regulator,
the Information Commissioner's Office ("ICO"), made
to its 2014 publication on big data, artificial intelligence,
machine learning and data protection, early last month. The
publication pulls out the distinctive considerations of the use of
big data from a data protection perspective. Such considerations
can include whether the collection of personal data goes above and
beyond what is needed for specific processing activities, whether
processing activities are made clear to individuals, and how new
types of data can be used. In light of the increasingly imminent
General Data Protection Regulation, as discussed in our previous
post, the ICO includes practical guidance for organizations to
process big data in a way that is compliant with the new rules.
Healthcare and other organizations looking to process big data will
need to ensure that they carry out suitable privacy impact
assessments and implement a range of protective measures, such as
auditable machine learning algorithms, anonymization and
comprehensive privacy policies. Guidance on profiling is also
likely to follow
We'll be keeping an eye on the work of the new task force,
as well as any further practical guidance that comes from data
protection regulatory agencies. It is clear that organizations will
need to get the balance right between potentially hugely speeding
up research and innovation by using big data, and adhering to the
regulatory obligations that are attached.
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guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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