Annexes to COM(2014)219 - Green paper on mobile Health ("mHealth") - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2014)219 - Green paper on mobile Health ("mHealth"). |
|---|---|
| document | COM(2014)219  |
| date | April 10, 2014 |
The EU-US Memorandum of Understanding (MoU) on eHealth/Health IT is a good example of cooperation as it seeks to facilitate more effective use of health-related ICT to support the health of the population, while strengthening the EU-US relationship and supporting global cooperation in that area.
In the field of medical devices, regulatory convergence is under way within the International Medical Device Regulators Forum (IMRDF)[59], set up in 2011 to replace the Global Harmonization Task Force. Its participating regions (US, EU, Canada, Japan, Australia, Brazil, China and Russia) recently endorsed key definitions for software that are medical devices.
Considering mHealth's cross-border dimension and its potential contribution to sustainable healthcare systems and the economy, stronger support is needed for more regulatory convergence in the field and the exchange of good practice internationally.
Questions: · Which issues should be tackled (as a priority) in the context of international cooperation to increase mHealth deployment and how? · Which good practice in other major markets (e.g. US and Asia) could be implemented in the EU to boost mHealth deployment?
3.11. Access of web entrepreneurs to the mHealth market
One of the conditions for the successful uptake of mHealth is the web entrepreneurs' capacity to enter this promising market, which is crucial to support the European ambition of becoming a front-runner in this field.
The Digital Agenda for Europe supports a series of entrepreneurship initiatives under "Startup Europe[60]"- a platform for tools and programmes supporting people who want to set up web start-ups in Europe. This could contribute to stimulating the market entry of European web entrepreneurs on the mHealth market.
In addition, the Commission launched a study called "Eurapp" to understand the impact of the app economy in Europe on growth and job creation. This understanding will ensure a better implementation of the web entrepreneur actions of the Digital Agenda and other initiatives.
The eHealth Action Plan 2012-2020 also puts forth actions that support web entrepreneurs: networking of European high-technology accelerators to give advice (e.g. legal, financial, technical) and training to eHealth start-ups. This should improve the market conditions for entrepreneurs developing products and services in the fields of eHealth and ICT for wellbeing.
Questions: · Is it a problem for web entrepreneurs to access the mHealth market? If yes, what challenges do they face? How can these be tackled and by whom? · If needed, how could the Commission stimulate industry and entrepreneurs involvement in mHealth, e.g. through initiatives such as "Startup Europe" or the European Innovation Partnership on Active and Healthy Ageing?
4. Next Steps
All interested parties are invited to submit their views in response to the above questions. Contributions should be sent to the following address to reach the Commission by 3 July 2014 at the latest:
CNECT-GREEN-PAPER-mHealth@ec.europa.eu.
European Commission
DG Communications Networks, Content and Technology
31, Avenue de Beaulieu
Unit H1, Health & Well-Being
Brussels 1049 - Belgium
The consultation can also be responded to on the website of the Digital Agenda for Europe, under the section "consultation".
As a follow-up to this Green Paper and on the basis of the responses received, the Commission will announce possible next steps in the course of 2015.
Contributions received will be published on our website unless a contributor requests otherwise. It is important to read the specific privacy statement accompanying this Green Paper for information on how your personal data and contribution will be dealt with.
[1] World Health Organisation “mHealth – New horizons for health through mobile technologies, Global Observatory for eHealth series – Volume 3”, page 6
[2] Lifestyle and wellbeing apps primarily include apps intended to directly or indirectly maintain or improve healthy behaviours, quality of life and wellbeing of individuals.
[3] European Commission eHealth Action Plan 2012-2020 Innovative healthcare for the 21st century, 07.12.2012
[4] PWC "Socio-economic impact of mHealth", page 17.
[5] ITU "Measuring the Information Society" 2012.
[6] World Health Organisation “mHealth – New horizons for health through mobile technologies, Global Observatory for eHealth series – Volume 3”.
[7] GSMA and PwC, Touching lives through mobile health - Assessment of the global market opportunity February 2012.
[8] Frost & Sullivan (2008) "Mobile/Wireless Healthcare Technologies in Europe "
[9] GSMA, Socio-economic impact of, mHealth, June 2013.
[10] IDC "Worldwide and U.S. Mobile Applications, Storefronts, Developer, and In-App Advertising 2011-2015 Forecast: Emergence of Postdownload Business Models".
[11] IHS report "The World Market for Sports & Fitness Monitors—2013 Edition".
[12] Research2Guidance (2013), "The mobile health global market report 2013-2017: the commercialisation of mHealth apps" (Vol. 3).
[13] Idem as previous.
[14] Deloitte study "mHealth in an mWorld", 2012.
[15] See also section 3.8 on "Big data".
[16] Boehm. E, Mobile Healthcare’s Slow Adoption Curve, 2011, Forrester Research, Inc.
[17] Blue Chip Patient Recruitment. Leveraging Mobile Health Technology for Patient Recruitment, October 2012
[18] Financial Times, Health apps run into privacy snags, 1.09.2013
[19] See accompanying Staff Working Document on the existing EU legal framework applicable to wellbeing apps, paragraph on Right to privacy and to data protection.
[20] See the Opinion 2/2013 of the Article 29 Working Party of 27 February 2013 on apps on smart devices.
[21] Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, OJ L 281/31, 23.11.1995.
[22] Commission proposal for a regulation on the protection of individuals with regard to the processing of personal data and on the free movement of such data, COM(2012) 11.
[23] Improving Public Health and Medicine by use of Reality Mining, Pentland. A, et al 2009, Robert Wood Johnson Foundation.
[24] McKinsey report, Big data: The next frontier for innovation, competition, and productivity, May 2011.
[25] Cloud computing refers to the storing, processing and use of data on remotely located computers accessed over the internet.
[26] COM(2012) 529, "Unleashing the Potential of Cloud Computing in Europe", 27.09.2012.
[27] See accompanying Staff Working Document "on the existing EU legal framework applicable to lifestyle and wellbeing apps", paragraph on right to privacy and to data protection.
[28] See eHealth Action Plan 2012-2020 - Innovative healthcare for the 21st century, page 9-10
[29] Resolution of 14 January 2014, http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+TA+P7-TA-2014-0010+0+DOC+XML+V0//EN
[30] Directive 93/42/EEC on medical devices, OJ L169,12.07.1993. This directive is currently under review to become a regulation.
[31] Directive 98/79/EC on in vitro diagnostic medical devices, OJ L331, 7.02.1998. This directive is currently under review to become a regulation.
[32] In the United States the Food and Drug Administration (FDA) published in September 2013 a Guidance on Mobile Medical Applications to inform app manufacturers and distributors about how it intends to apply its regulatory authority to apps intended for use on mobile platforms. The FDA approach calls for oversight of only those mobile apps that are medical devices and whose functionality could pose a risk to a patients' safety if the app does not function as intended.
[33] Research2Guidance (2013), "The mobile health global market report 2013-2017: the commercialisation of mHealth apps" (Vol. 3).
[34] The New England Center for Investigative Reporting, Boston University, "Lacking regulation, many medical apps questionable at best", 18.11.2012.
[35] An example of a standard on user safety is the draft standard IEC 82304-1 of the International Electrotechnical Commission (IEC). It contains requirements for software that are medical devices, while intended to be used with a broader scope, such as for health and wellbeing purposes.
[36] Another example is the AppSaludable Distinctive created by the Andalusian Agency for Healthcare Quality, an app certification programme.
[37] See the 2012 Ageing Report: Economic and budgetary projections for the 27 EU Member States (2010-2060), chapters 3 and 4
[38] Mc Kinsey and GSMA, "mHealth: A new vision for healthcare", 2010.
[39] World Health Organization, mHealth - New horizons for health through mobile technologies 2011
[40] Article 15 of Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare, L 88/45, 4.4.2011.
[41] Special Eurobarometer 381 E-COMMUNICATIONS HOUSEHOLD SURVEY, June 2012.
[42] http://ec.europa.eu/digital-agenda/en/connected-continent-legislative-package.
[43] The new EU funding programme for research and innovation for the period 2014-2020.
[44] SemanticHealth study definition "Interoperability is where two or more eHealth applications (e.g. EHRs) can exchange, understand and act on citizen/patient and other health-related information and knowledge among linguistically and culturally disparate clinicians, patients and other actors or organisations within and across health system jurisdictions, in a collaborative manner."
[45] However, some international and European standardization committees, such as IEC, CEN-CENELEC, ISO have an increased number of working groups related to health informatics.
[46] 30% of mobile app developer companies are individuals, while 34.3% are small companies (defined as 2-9 employees) according to IDC "Worldwide and U.S. Mobile Applications, Storefronts, Developer, and In-App Advertising 2011-2015 Forecast: Emergence of Postdownload Business Models".
[47] eHealth Task Force report recommendation.
[48] E.g. SNOMED CT is one of the most comprehensive, multilingual clinical terminology in the world and is composed of more than 300.000 concepts and about 1 million descriptions.
[49] The slow computerisation of healthcare systems is another issue that impedes the provision of integrated care.
[50] http://ec.europa.eu/isa/actions/documents/isa_2.12_ehealth1_workprogramme.pdf
[51] http://ec.europa.eu/health/ehealth/docs/guidelines_patient_summary_en.pdf
[52] Article from McKinsey & Company "Engaging consumers to manage health care demand", January 2010.http://www.mckinsey.com/insights/health_systems_and_services/engaging_consumers_to_manage_health_care_demand
[53] "My VisonTrack has worked closely with a large pharmaceutical company in clinical trials. The partner may provide the app to the user for free and reimburse my VisonTrack directly.", Comparison of US and EU Regulatory Approaches to Mobile Health Apps: Use Cases of Myvisiontrack snd USEFIL, European Journal of ePractice, n°21, page 40.
[54] IMS Institute for Healthcare Informatics "Patients apps for improved healthcare, from novelty to mainstream", October 2013
[55] The new EU funding programme for research and innovation for the period 2014-2020.
[56] WHO report "mHealth - New horizons for health through mobile technologies", 2011. - WHO Countries in the European Region are currently the most active and those in the African Region the least active
[57] NCDs are diseases that cannot be passed from one person to another such as cancer, heart disease or diabetes.
[58] Mobile solutions will be primarily sms or apps based and will include a range of services focused on awareness, training, behavioural change, treatment and disease management etc.
[59] The IMDRF is a voluntary group of medical device regulators from around the world, to discuss future directions in medical device regulatory harmonization and to accelerate international medical device regulatory harmonization and convergence.
[60] https://ec.europa.eu/digital-agenda/node/67436