+ M Health solutions
+ Why Regulate ?
+ What Regulations help or hinder ?
+ Next steps
2) Which markets are we trying to address with mHealth ( my definition is based on
Mobile Internet, as a part of EHealth) ?
+ Access to prevention , cure and care (NB lack of specialists /clinicians internationally)
+ Better access to information, clinicians and drugs (NB reliability of trusted sources , but
Mobile Internet could play a big part)
+ Measurement at point of care (NB reliable devices and multiple conditions. Yet trend
towards wearables for Wellness and self care already )
+ Transmission of data to clinicians (NB Reliable data through Telecare and Telehealth,
to trusted clinicians, to assist Diagnosis)
+ New approaches to healthcare with productivity or cost saving benefits (NB Changes to
the Health and wellness systems as well as the patient)
+ Patient centred care ( NB Accessibility and inclusion , whether in the home with
LTC's, or in the workplace or on holiday ; sometimes requiring remote access to patient
records; Prevention as well as Cure ; support to the elderly and infirm )
Mobile Internet can contribute to all these now......
3) Why do we need to regulate or certify this innovation ?
+ Understanding and awareness ; informed patients and illness prevention
+ Patient confidence and trust
+ Cross sector system reliability
+ Distribution channel development
+ Record keeping and data collection
+ Productivity based on standards
+ External audit or certification
+ Patient safety
Change isn't easy but EHealth (incl mHealth) is a major force in transforming Health and
4) What regulations are affecting this innovation and trends to better eHealth ?
+ Medical or Connected or Radio devices Directives ?
+ Data Privacy and Protection (NB Cloud services ; remote diagnosis internationally ;
patient support groups on the Internet )
+ Mobile Health Apps regulation (NB FDA - USA and EU differences need to be
minimised as patients want to travel too ) For example what is wrong with patient
support groups recommending specialist Apps / solutions as we see in the 2ND
Directory : myhealthapps.net from Patient view
+ Payment services
+ Consumer protection
+ Skills definition and certification – eg training in ICT
Navigating between separate regulations remains a real challenge to mHealth / eHealth
innovation and productivity
+ Mobile Internet is a major force for good in healthcare
+ Good reasons for building further trust in Mobile based EHealth
+ Solutions will multiply for Patient centred Care and better Healthcare
+ Regulation needs to be addressed but is challenging
+ Safety and solutions for patients need to work together .....hand in hand
We need proportionate and balanced regulation in this area , to provide better solutions for
everyone . MHEALTH has so much to contribute and the innovation has only just begun .
Lets also use MHEALTH to remove disability from the Digital world .