EU mhealth Working Group

Transcription

1

2 EU mhealth Working Group

3 500 million users publishers 5% of total app market 3bn downloads

4 Status Guidelines for assessing reliability & validity Lots of work on Scope, Target Group & Criteria

5 SubGroup 1 Focus on Scope & Criteria Chair a subgroup of the working group looking at Scope and Criteria of the mhealth guidelines resulting from the work of the mhealth working group. Challenge being addressed 2 Criteria? Reliability Validity 9 Criteria? Reliability Stability Effectiveness Usability Transparency Privacy & Security Safety Credibility Desirability

6 Discussion Why we were developing the guidelines and who we thought these were for? Who benefits most from the guidelines? Where can guidelines have largest impact?

7 Targets Users and citizens? Individual health professionals? Suppliers? Health care providers Best way to help suppliers is to build confidence in order to support the creation of the mhealth market. By targeting the support at health care providers and detailing how they should assess apps, we are indirectly providing suppliers with the blue print of the standards required for development at a European wide level.

8 Conclusion Reason for the guidelines - help educate and facilitate Should we get involved in the Consumer market? The key issue in mhealth is the adoption and deployment of health apps by the health system How to identify and judge good & trusted apps, which can be safely deployed? Conclusion Provide most value targeting health care provider organisations, as the gatekeepers to the market. Citizens, Healthcare professionals and suppliers are the indirect beneficiaries.

9 Scope & Criteria Based on Agreed Target Are 9 criteria are important or should scope be limited? Discussions Some criteria are black and white, can be developed to and have existing standards. Others are subjective. E.g. desirability. Difficult to build a desirable product from a specification of it needs to desirable. The difficulty in naming the criteria and finding a common terminology for a number of criteria which is understood across different user groups such as health professionals, developers, academics and professionals.

10 Summary 1. Target Health Care Organisations 2. Broader Criteria are useful General consensus that all the 9 criteria are important The maximum value derived from targeting the guidelines specifically at healthcare organisations. Healthcare organisations, were best served by being guided through 9 broad criteria. 3. Required & nice to haves Desirability may well impact the usage of an application and therefore the benefit and efficacy & resulting health outcomes. But can t be developed to, so grouping of criteria required, which may lie with the opinion of the healthcare organisation.

11 Other elements discussed Off label usage - Deemed out of scope Reasoning: Difficult to target, reach or engage apps, which have no intention of being in the health or medical space, into this process Difficult to provide guidance to assessors assessing apps other than for their intended use. Involves complex notion of developing alternate use cases for all sorts of apps, is difficult to scope and to contain. There were additional concerns on the following: Guidance vs Regulation Next Steps & Roadmap for Guidance How the various areas of EU work fit together, e.g Code of Conduct on Privacy

12 20% of people don t download due to lack of Trust TRUST It s about building confidence

13