Patient remote monitoring system in Wearable Technology

WebinarPatient remote monitoring systemPrivacy, medical devices and IP related issues of patient remote monitoring systems and wearable technologies in the healthcare sector

Global Lawyers Association

Giulio Coraggio

DLA Piper Italy

giulio.coraggio@dlapiper.com

December 19, 2013

We already talked about wearable tech…

giulio.coraggio@dlapiper.comGiulio Coraggio - DLA Piper 2

Wearable technologies in the healthcare sector

Remote patient monitoring (RPM), also called homecare telehealth, is a type of ambulatory healthcare that allows a

patient to use a mobile medical device to perform a routine test and send the test data to a healthcare professional in real-time.

giulio.coraggio@dlapiper.comGiulio Coraggio - DLA Piper 3

What type of technologies are relevant?

giulio.coraggio@dlapiper.comGiulio Coraggio - DLA Piper 4

How does it work? Cloud projects!

giulio.coraggio@dlapiper.comGiulio Coraggio - DLA Piper 5

Potential legal issues…

Privacy – collection, transfer and processing of patients' personal data;

Medical device regulations – potential qualification of hardware and software as medical devices;

IP rights – how to protect the technology and the exclusivity rights on its exploitation

giulio.coraggio@dlapiper.comGiulio Coraggio - DLA Piper 6

Processing of patients' data

Which data protection law applies?

Opinion of the EU Working Party

What consent and authorizations are required and from who?

And in the case of biometric data?

giulio.coraggio@dlapiper.comGiulio Coraggio - DLA Piper 7

Who does what?

Understanding of the entities involved hospitals

patients

sponsor

technology provider

What are their roles? data controller

data processor

sub-processor

Consequences on the purposes of processing of collected data anonymous data

giulio.coraggio@dlapiper.comGiulio Coraggio - DLA Piper 8

Transfers of patients' data outside of the European Union

Approval from hospitals (data controller) as part of public tenders When can it be implied? Is it negotiable? Can the denial be

challenged?

Privacy-related options Patients' consent

Binding corporate rules

Safe Harbor program

giulio.coraggio@dlapiper.comGiulio Coraggio - DLA Piper 9

Most common approach to manage data transfers

EU Model clauses data controller, data processor, sub-processor

possible restrictions if the data processor is within the European Union and the sub-processor(s) is (are) located outside of the European Union

giulio.coraggio@dlapiper.comGiulio Coraggio - DLA Piper 10

What other privacy issues to consider?

What consent and authorizations are required? and in the case of biometric data?

What security measures shall be adopted?

What data can be accessed? and by who?

For what purposes personal data can be used? patient treatment

clinical trials?

articles on journals?

giulio.coraggio@dlapiper.comGiulio Coraggio - DLA Piper 11

Is hardware treated as a medical device?

Qualification of the hardware: hardware which may also be used within the medical environment

are normally not considered as medical devices, unless they are specifically assigned a medical role

hardware utilized together with the software in such a way that the software may not otherwise run (i.e. the software would not run on any other device), then the hardware should be regarded as MD itself

giulio.coraggio@dlapiper.comGiulio Coraggio - DLA Piper 12

Is software treated as a medical devices?

Qualification of the software – this may be regarded as a medical device when either: his purpose of use falls under one of the categories listed in the

definition of medical device; or

it is intended to control or influence the functioning of a medical device; or

it is intended for the analysis of patient data generated by a medical device with a view to diagnosis and monitoring; or

it is intended for use for/by patients to diagnose or treat a physical or mental condition or disease.

giulio.coraggio@dlapiper.comGiulio Coraggio - DLA Piper 13

What is the impact on the growth of this technology?

Time to market?

CE Marking

Issues for updates/upgrades

giulio.coraggio@dlapiper.comGiulio Coraggio - DLA Piper 14

How are these devices protected?

IP rights on the technology?

Patentability of the software/hardware?

Trademark protection of generic terms by technology companies?

giulio.coraggio@dlapiper.comGiulio Coraggio - DLA Piper 15

Thank you!

Giulio CoraggioDLA Piper ItalyT +39 02 80 618 619 M +39 334 68 81 147 E giulio.coraggio@dlapiper.com

giulio.coraggio@dlapiper.comGiulio Coraggio - DLA Piper 16