Seminar om de nye regler for certificering

Transcription

1 Seminar om de nye regler for certificering Certificeringer af sundheds-apps Susie Wagner Bondorf Partner og med-stifter

2 Background ehealth Action Plan üa Green Paper on mobile health (mhealth) üpublic Consultation üstaff Working Document

3 Green paper definitions mhealth covers medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistants (PDAs), and other wireless devices It also includes apps such as lifestyle and wellbeing apps that may connect to medical devices or sensors (e.g. bracelets or watches) as well as personal guidance systems, health information and medication reminders provided by sms and telemedicine provided wirelessly

4 Benefits mhealth potential for healthcare üincreased prevention/quality of life approach ümore efficient and sustainable healthcare ümore empowered patients

5 Issues at stake üdata protection, including security of health data übig data üstate of play on the applicable EU legal framework üpatient safety and transparency of information ümhealth role in healthcare systems and equal access üinteroperability üreimbursement models üliability üresearch and innovation in mhealth üinternational cooperation üaccess of web entrepreneurs to the mhealth market

6 Research and Innovation Horizon 2020: Current initiatives üpersonalising health and care (PHC) Healthcare in your pocket: unlocking the potential of mhealth What mhealth can do for you Overview of ehealth projects Policy üprivacy Code of Conduct ümhealth assessment guidelines

7 EU guidelines on assessment of the reliability of mobile health applications Third draft of the guidelines will be published mid-october 2016

8 Three main groups of apps 1.CE marked medical devices. Additional focus areas like e.g. GUI 2.Other apps used in a medical setting. 3.Health & wellbeing apps. 3. Health & wellbeing apps 2. Other apps used in a medical setting 1. CE marked

9 Medical Devices Directive (MDD) The key criteria for medical devices are: üsafety (esp. S1) üefficacy (esp. S3) üstability (& Accuracy) (esp. S10.1) üreliability (esp. S12.1) ütransparency & credibility (esp. S12.1a) Not covered in the MDD: Measures of the ease or desire of usage, or security & privacy.

10 Process for guideline production First Iteration Followed by stakeholder engagement and written feed-back Second Iteration Followed by stakeholder engagement and changes to next draft in light of feed-back Third Iteration targeted for mid October To be followed by stakeholder engagement and changes to next draft in light of feedback Fourth (and Final) Iteration targeted for end December Final draft guidelines sent out for written comments to the extended stakeholder group. üwhen feedback received, final draft guidelines produced and discussed with Commission. üincluded in final report ( )

11 Focus groups ücitizens. üapp developers. ühealthcare professionals. üprivate & public healthcare providers, public authorities & health ins. providers.

12 A view to the engine compartment Scrutiny questions: Currently nine summary questions: üis the app usable & accessible? (repeat for each o/s) üis the app desirable to use? üis the app credible? üis the app transparent? üis the app reliable? üis the app technically stable? üis the app safe? üis the app effective? üis the app private & secure? Covered by Privacy C of C?

13 START 1. Is the mobile app a software according to the definition? Decision step 1:...For the purpose of this guideline, software is defined as a set of instructions that processes input data and creates output data. MEDDEV 2.1/6, July 2016 Decision tree Based on an existing from Andalusia, Spain. Out of the scope of the guidelines document No No YES 2. Is the app (functionality) intended to be used in Health domain? Yes 3. Is the app performing an action on data diferent from storage, archival, communication, or simple search Yes 4. Is the app (funcionality) for the benefit of the individual user/patient Decision step 3: if the software does not perform an action on data, or performs an action limited to storage, archival, communication, simple search or lossless compression (i.e. using a compression procedure that allows the exact reconstruction of the original data) it is not a medical device. Altering the representation of data for embellishment purposes does not make the software a medical device. In other cases, including where the software alters the representation of data for a medical purpose, it could be a medical device. MEDDEV 2.1/6, July 2016 Decision step 4: an example of software for the benefit of individual patients is software intended to be used for the evaluation of patient data to support or influence the medical care provided to that patient. Examples of software which are not considered as being for the benefit of individual patients are those which aggregate population data, provide generic diagnostic or treatment pathways, scientific literature, medical atlases, models and templates as well as software for epidemiologic studies or registers. MEDDEV 2.1/6, July 2016 Yes No No 5. Is the funcionality for the purposes defined in art.1,2a (MD) or art 1, 2b (accessory) of MDD Yes Medical Device or accessory to a MD Covered by the medical devices legal framework No Criteria A should apply 6. Is the app intended to interact with EHRs? Yes NO Criteria B should apply Criteria C should apply Criteria D should apply Criteria E should apply

14 If your shop assistant was an app

15 Further information Find the first draft of the guidelines here: Stakeholder questionnaire: Thank you!

16 Extra If we have the time

17 üdata protection Related Initiatives (1) industry-led privacy code of conduct for mobile health apps (process started in Apr 2015) ümedical devices legislation New regulations negotiated in the Council and EP Updated MEDDEV guidance 2.1/6 on qualification and classification of stand-alone software Updated Manual on Borderline and Classification (two new entries on mobile apps for the assessment of moles) üdigital Single Market strategy (6 May 2015) Public consultation on safety of apps and other non-embedded software (to be launched in May 2016)

18 Related initiatives (2) üeuropean standard on quality criteria for the development of health and wellness apps based on the PAS 277:2015 on Health and wellness apps Quality criteria across the life cycle (UK) does not cover requirements for apps that are classified as medical devices üpolicy discussions at the Member States level (ehealth Network subgroup on mhealth) üwho-itu innovation hub for mhealth (under H2020)