"mHealth: Should we regulate" Presentation by Bleddyn Rees, Osborne Clarke

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Digital Health & Wellness Summit
Mobile World Congress Barcelona, February 2016
mHealth: Should we regulate?
Bleddyn Rees T: @bleddyn_rees E: bleddyn@osborneclarke.com

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Two Questions raised by the title of the session
"mHealth should we regulate?"
• "Technology develops rapidly. The law does not. In consequence, and with increasing
frequency, new technology is being introduced into a legal environment that was not designed
to accommodate it". John Cooper
• Telegraph Act 1869: new technology colliding with old law is not new – telegrams & the newly-
invented telephone (Attorney General v Edison Telephone Company 1880).
• Firstly, who should regulate?
• Secondly, if so, what subject or matters should be regulated?

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1. What is eHealth, mHealth, telehealth & telecare?
• No legal definitions in EU or UK law & no agreed industry defintions!
• WHO has adopted the following broad definition of eHealth:
“the overarching term for the range of tools based on information and
communication technologies used to assist and enhance the prevention,
diagnosis, treatment, monitoring and management of health and lifestyle”.
• WHO has not adopted a definition for mHealth. The 2010 mHealth
Summit of the Foundation for the National Institutes of Health defined
mHealth as:
“the delivery of healthcare services via mobile communication devices”.

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2. Overview of mHealth Services
MHealth involves the combining of products and services from device
manufacturers, telecommunications companies and software producers
with some healthcare aspect. This creates three types of services/markets for
(1) health professionals, (2) health management and (3) prevention and well being.

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3. Overview of the Regulatory Challenge
Sources of EU applicable legislation
CitizensandPatients
Clinicalandsocialcare
Vendors, suppliers, commercial partners
Government, policymakers, payers
TRADE & COMPETITION LAW
PRODUCTS&SERVICESLIABILITYLAW
Dir97/7/EC,99/93/EC,2000/31/EC,2005/29/EC
DATAPROTECTIONLAW
Dir95/46/EC,2002/58/EC,2006/24/EC
Monitoring
HIS eRX OR
Summary
records
DSS
CPOE
Health Information
Labs
GPs
PACS
Home
care
EHR
20169315v1
Source: Legally eHealth EC Report March 2008

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4. 12 Legal & Business Challenges which may
justify regulation?
1. Data Security – fears about hacking and misuse of information (Insurers?)
2. Whose data is it? (Ownership)
• Is it Health System (NHS/Government/GP/Hospital or combination)?
• The Patient’s?
• Some combination of Patient and Government?
3. Data Protection (European Directive 95/46EC) and Patient Informed Consent
• Anonymised and pseudoanonymised data

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4. 12 Legal & Business Challenges which may
justify regulation?
4. What information constitutes the record?
• Secondary care information
• Primary care information
• Standardising structure and content of medical records
• Royal College of Physicians 2008 generic medical record keeping standards for medical notes
and standards for admission, handover and discharge records
• RCP elearning modules on record keeping (www.igte-learning.connectingforhealth.nhs.uk)
5. Distinction between Medical Record and Personal Health Record (Information)?
• Allowing Patients “interactive” access to clinicians
• Need to preserve integrity of clinical information/record
• Future of patient reported information: factual and self monitoring devices/ observations? Is the
information reliable? Does it matter?

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4. 12 Legal & Business Challenges which may
justify regulation?
6. Information & Patient Contact (Worried Well) overload for clinicians and legal liability for failure to
notice or act on critical data?
7. Intellectual Property Rights in “Big” data & R&D programmes
8. Health Laws Compliance Requirements for each EU state in which services provided.
9. Telecommunications v healthcare v professional regulation? What are the services?
10. Liability concerns: product liability v clinical negligence risk & (liability of teleco’s for information
carried or not?)
11. Is it a device or service or combination?
12. Advertising & Marketing restrictions applicable to certain healthcare service

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5. Concluding thoughts
• Is regulation a barrier to innovation? Does an absence of regulation boost growth and productivity?
• "Difficulties occur in regulatory law not because there is too much of it – on the contrary, there is often
too little – but because it is frequently not good enough". John Cooper
• Businesses want clarity and certainty as to what the regulatory environment looks like.
• A wish for a harmonised healthcare regulatory system across the EU!
• "It is not sufficient that the state of affairs that we seek to promote should be better than the state of
affairs that preceded it, it must be sufficiently better to make up for the evils of transition".
J.M. Keynes