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  • 1. Agenda + 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 wellness 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 European Directory : myhealthapps.net from Patient view
  • 2. + 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 5) Conclusion + 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 .