MEDICALSOFTWARE. The Netherlands, ehealth world leader!

Transcription

1 MEDICALSOFTWARE The Netherlands, ehealth world leader!

2 MEDICALSOFTWARE Management Summary The healthcare industry is rapidly moving towards a digital transformation where personalized medicine and patient-empowerment prevail. Healthcare professionals predict a positive contribution of digital applications in healthcare, but they are desperately in need of more clarity about the quality and liability. In this article we will prove that to truly get to the upscaling of medical apps. The apps must comply with CE certification requirements. The industry challenge is to find a (new) way to certificate and validate new promising applications in this rapidly changing environment. This whitepaper describes a possible way to realize this challenge and the results of a survey among more than 300 Dutch healthcare professionals. 1 During the ehealth Week 2016, Minister of Health Mrs. Edith Schippers announced that 20 million will be made available for the stimulation of ehealth. According to the minister, the nation-wide implementation and scaling up of ehealth initiatives is currently the main challenge. Her aim is to bring promising initiatives sooner to patients and to give them a place in the care process. An important condition to truly get to the upscaling of apps is that the medical apps will comply with CE certification requirements and best practice thus, eliminating the two major barriers that withhold healthcare professionals from actually getting started with (new) digital applications. The two barriers are: (a) Clarity about the quality (b) Clarity about the liability During the ehealth Week, the European commission also presented the 2nd draft of the new guidelines for mhealth apps. These guidelines will become effective in The second part of this whitepaper deals with these new voluntary guidelines in relation to the new Medical Device Regulation (MDR) that will be published in 2017 too. If we go about the guidelines and the new MDR in the right way, The Netherlands, can become the true world leader in ehealth!

3 Survey VvAA Mobile Doctors and Inzentiz BV conducted a survey among more than 300 Medical apps make a positive contribution to healthcare medical specialists and General Practitioners (GPs) to gain more insight into the views of healthcare professionals about using apps. A vast majority of GPs (64%) and medical specialists (71%) who participated in the study believe that medical apps make a positive contribution to healthcare. Definition People show more restraint in the field of prevention. 40% of GPs and medical This survey is based on the following definition of medical apps: specialists believe that medical apps can contribute to the prevention of diseases. Medical apps are apps that must be certified and comply with the regulations (CE) for medical devices. These medical apps can be used to monitor health. For example by measuring sleep patterns or the heart rate. The data can Concrete local policy is absent be used by the physician in the diagnosis and/or treatment. This way the physician or the patient may receive notifications, for example about the intake of medication. In short, the healthcare professionals from the survey see a significant contribution of medical applications in healthcare. Remarkably enough, no policy has been formulated for the use of medical apps in 2 Interest in medical applications is undiminished The prominence of medical apps among the surveyed GPs and medical specialists is high, 94% and 92% respectively. Almost half (45%) of the GPs who participated in the study have at least at some point prescribed an app. With medical specialists, this is one in five. A few apps that were mentioned are Thuisarts, Moet ik naar de dokter and Huidmonitor. The main reason to prescribe medical apps is the self-reliance of the patient. A lack of familiarity with the possibilities plays an important role with those who haven t yet prescribed the use of medical apps. 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% the doctor s offices and (health) facilities where the GPs (1%) and medical specialists (9%) are active. Did you, the (health) facility or the doctor s office where you work formulate a policy for the use of (medical) applications? GP (n=106) 5% 23% 94% 68% 1% 9% Medical specialist (n=190) Yes No No answer

4 Who is responsible for the quality? We also asked healthcare professionals about the responsibilities regarding the use of apps. When it comes to meeting the certification requirements, a quarter believes that professional organizations such as the Royal Dutch Medical Association (KNMG) are responsible and another quarter points in the direction of the medical app developer. People are more outspoken about the quality. Approximately 40% of respondents believe that the medical app developer is responsible for this, and indeed: they are. Only 27% of respondents know that the Inspectorate of Health Care is responsible for enforcing the law on medical equipment while 24% thought the Royal Dutch Medical Association (KNMG) was responsible for this. Who do you think has the main responsibility for the quality of medical apps? 3 GP Medical specialist The government 6% 5% The healthcare professional 11% 21% The patient 0% 3% Professional bodies such as the KNMG 23% 20% Patient organizations 4% 3% Inspectorate of Health Care (IGZ) 9% 8% The medical app developer 42% 37% Health insurers 2% 1% Who is liable for the costs of errors? From the results of the survey, it is completely unclear where the liability lies when using medical apps. 80% of both GPs and medical specialists indicate that it is (very) unclear who is liable for any errors arising from the use of medical apps. 40% of this group is actually worried about this lack of clarity. The uncertainty seems understandable, since it is rather complicated to know who is liable for damages that are caused by errors due to the use of a medical app. When an app is not CE certified, but it is used by a physician in his diagnosis or treatment plan, the care professional is certainly liable for any resulting damages. When the app is CE certified, it may be that the physician is still liable when he made use errors, but in general the legal manufacturer will be the first to be held accountable for the damage. The judge will have to decide whether the manufacturer is liable for the damage, but as a rule of thumb one can say that when the manufacturer can prove he has done everything necessary to comply with the law, the manufacturer will not be punished but will have to adjust his product and perform the eventually demanded corrective actions.

5 Besides medical applications (these are apps that for their functionality must meet the regulations for medical devices), there are also non-medical applications: the so-called lifestyle apps. For these apps, the efficacy and hence the risk to human health are so low that they are not deemed as a medical device. Lifestyle apps therefore contribute less to the improvement of care*. Precisely regarding these lifestyle apps, clarity is needed: There are hundreds thousands of them and nothing has been settled with regards to the (clinical) quality and liability. Adding to that, many lifestyle apps will push the boundaries in order to: (a) not be a medical device (and thus avoiding the costly certification) but, (b) still trying to mean as much as possible to health care. Those apps are called grey-zone app according to the European Commission. During the ehealth week, Andrew Ruck, who is contracted as Development Leader of the EU commission guidelines, presented the 2nd draft of the new guidelines for mhealth apps. These guidelines are voluntary and are expected to be applicable in The objective is to separate the wheat from the chaff: the guidelines contain nine criteria for assessing quality which healthcare organizations may use to assess the reliability and validity of the lifestyle apps. The European commission also said was that the new regulation of medical devices (the MDR) will cover some aspects of the current grey zone. Since the MDR is mandatory, some (but not all) of the current grey zone apps should expect to need to demonstrate compliance to this MDR. Or as Andrew Ruck formulated it: The medical devices regulatory framework applies already now to all software that falls under the definition of a medical device. According to the relevant legal framework on medical devices, qualification and classification decisions rely primarily on Member States. Andrew Ruck: We also intend to include a case study on the guidelines from the Netherlands, if the Dutch members of the EU Working Group (red.: the NICTIZ) wish to submit one. The problem of non-certified mhealth apps not only plays in Europe, but also in the United States: The phenomenon of grey-zone applications also exists over there. In fact, the ehealth market in the US is more advanced than in Europe, but the vast majority of apps there are also not FDA approved. To break this ehealth deadlock and at the same time achieve her goal to stimulate the roll-out of ehealth applications that will be widely adopted by care professionals, the minister could encourage suppliers to start making CE certified apps. In that way, she would not only realize her own goals, but it would also immediately make The Netherlands the world leader in the field of effective ehealth deployment. The NICTIZ can, as the Dutch member of the EU Working group, play, together with the Dutch Health Care Inspectorate (IGZ)a prominent role in the mentioned case study. The Commission has been constantly engaged in providing (non-binding) guidance in view to facilitate implementation and provide clarity to authorities and economic operators. In the medical software/applications field, the MEDDEV guidance on medical software and the Manual on Borderline and Classification are the two main instruments for reducing the grey zone as much as possible. It is the intention of the Commission to strengthen these instruments even more in the years to come. This work will be taken forward by the Software Working Group managed by DG GROW under the Medical Devices Expert Group (MDEG). The MDR will be published early 2017 (after two last review rounds) and will become mandatory in Based on this statement, grey-zone apps would be wise to comply with the regulations for medical devices and thus CE certification already now since this will have significant benefits to them: (a) the application shows that it meets the highest quality standards; (b) The liability is well regulated for certified apps (see above); (c) you can let the certified app do more for the healthcare (d) healthcare professionals are familiar with CE certification: All their medical equipment meet it and (e) the functionality of certified apps will thus fit better in existing reimbursement schemes. And: The Netherlands have a golden opportunity! The Netherlands could be one of three pilot countries that implements the new guidelines and new MDR directives in an early stage. It could be immediately indicated after the implementation in 2017 who the grey-zone apps are and every grey-zone app can then choose whether they want to adapt the new, voluntary directive or the CE certification. * Risk class and the efficacy of apps. The certification of apps is an expensive and complicated process, especially for products with the higher risk classes IIA and IIB. Overall you can say that apps that are used for medical measurements are CE class I: Apps that are used for diagnosis are CE Class IIA and apps that are used for treatments are CE class IIB. The beauty of certified apps is that they can do more for the healthcare (medical measurement, diagnosis and even treatment) since both the quality and liability of certified apps are properly regulated. 4

6 Research Accountability Is described by Research accountability This whitepaper is based on a survey amongst members of VvAA. VvAA is a member organization for more than Dutch healthcare professionals and healthcare institutions. The survey questionnaire is created in a co-operation between Inzentiz BV and Mobile Doctors (an initiative of VvAA). The online survey fieldwork took place between April 21, 2016 and May 9, The respondents received an invitation with a link to the questionnaire. In total we invited healthcare professionals. This resulted in a net response of 312. Representing a response rate of 18%. The research sample exists out of 113 general practitioners and 199 medical specialists. 64% of the respondents is man and 36% woman. Classification on age is year (13%), year (22%) and year (65%). If you have any questions about the research please contact us at: redactie@mobiledoctors.nl 5 About INZENTIZ INZENTIZ BV was founded in The INZENTIZ Mobile Software Platform provides the software framework for medical devices involving mobile devices and cloud services. It is a high-tech platform that simplifies mobile care and improves patient experience in a safe and CE and FDA compliant environment. With the INZENTIZ platform you will have three times less work (time and costs) and thus a much faster market release for a CE or FDA certified mhealth solution. The four founders together have more than 70 year experience in the medical software industry and work together since They developed more than 15 CE and/or FDA approved software applications in various areas like radiation therapy, medical databases, infection prevention and epilepsy-video monitoring. They transport their expertise from the medical device industry to the mhealth world via the INZENTIZ mobile medical software platform and recently received a considerable EU grant for the development of the platform.