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mHealth Regulations:
Global Efforts and Readiness
As mobile device use becomes pervasive in healthcare, regulatory agencie...
2
“One key challenge
for application
developers and
other stakeholders
who seek to
promote adoption
of innovative apps
on ...
3
regulate mHealth (going beyond the
boundaries of medical devices/drugs)
will become essential over time. Future
mHealth ...
4
2.	 The FDA will review only those
mobile apps that have potential
to harm the consumer.
3.	 The FDA will regulate both ...
5
International group working
on recommendations
In addition to these attempts at defining
mHealth regulatory frameworks i...
6
affordability, reach and availability issues.
The following are some of the key
developments we predict will occur in
th...
This white paper is for information purposes only, and may contain typographical errors and technical inaccuracies. The co...
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  1. 1. mHealth Regulations: Global Efforts and Readiness As mobile device use becomes pervasive in healthcare, regulatory agencies address patient safety, privacy and need for innovation. March 2014 Balancing safety and innovation mHealth, short for mobile health, has become a disruptive force in healthcare, changing the way clinicians and patients interact with technology. With the development of a wide range of mobile medical applications, regulatory agencies must rethink the very definitions of medical devices. While patient safety and privacy are paramount, many stakeholders are advocating for regulations that do not stifle innovation. The global response: advocacy, collaboration As regulatory bodies formulate their response to mHealth, an international collaboration is developing, seeking to provide a global standard. Through this paper, we will look at current regulations and guidelines that address requirements for mobile health in various regions. We will also take stock of efforts currently underway to ensure that future regulations strike the right balance between patient safety and encouraging innovations.
  2. 2. 2 “One key challenge for application developers and other stakeholders who seek to promote adoption of innovative apps on a large scale is the nascent and unclear regulatory environment.” Almost half of all respondents in the Epocrates survey are digital omnivores — clinicians who utilize a tablet, smartphone and laptop/desktop computer routinely in a professional capacity. mHealth is largely enabled today by mobile handsets, tablets, personal digital assistants, patient monitoring devices and other wireless devices. With the overwhelming adoption of these devices by the healthcare community, mHealth can be applied: • Across all aspects of health, including wellness, prevention, illness and recuperation • Across all healthcare delivery settings, including home health, remote health, outpatient care, day care, acute care, sub-acute care, hospice and long-term care • To different end uses, such as remote health monitoring, reminders and scheduling, research, clinical decision support and medical training • To a wide variety of users such as: –– Physicians, nurses and other healthcare professionals –– Patients –– Healthcare payers –– Governments –– Medical device providers –– Pharmaceutical entities mHealth is expected to change the way healthcare is conceived, monitored, delivered and accessed in the years to come. As with every disruption, mHealth also has its own set of challenges. One key challenge for application developers and other stakeholders who seek to promote adoption of innovative apps on a large scale is the nascent and unclear regulatory environment. Unanswered questions concerning the acceptance and viability of these mobile apps have contributed to hesitation and longer cycles of adoption. This is especially the case for higher-end apps (which generally are the most useful). The recent issuance of guidelines by the Food and Drug Administration (FDA) in the USA on September 25, 2013, is probably the most concrete step toward addressing this pressing need for regulatory clarity around mHealth. The regulatory requirements available for mHealth have so far been mostly linked to those applicable to medical devices or, in some cases, to those applicable to drugs. The regulatory agencies meant for regulating medical devices and/or drugs have issued these guidelines and are working on providing further clarity on the regulations for mHealth. So far, the Food and Drug Administration (FDA) in the USA, the European Medicines Agency (EMA) in the EU and the Therapeutic Goods Administration (TGA) in Australia have issued such mHealth guidelines. However, because mHealth merges the interests of healthcare, manufacturers of medical devices and drugs, telecommunications players and healthcare IT, a holistic approach to mHealth is proving to be a disruptive technology in healthcare by addressing many of the industry’s key concerns, including affordability, availability, accessibility, accountability and assurance. A 2013 Epocrates survey of mobile device use by clinicians reported that by 2014 “9 in 10 healthcare providers will use smartphones, and nearly as many will have adopted tablets.”1
  3. 3. 3 regulate mHealth (going beyond the boundaries of medical devices/drugs) will become essential over time. Future mHealth regulations and guidelines are expected to address the following: • Classification of mHealth applications according to their need for depth of regulatory oversight, using multiple variables such as safety, failure impact, nature of data captured/carried/retrieved. Clear definitions of these classifications and the dispute handling mechanism will be crucial. • Definition of certification requirements for each category and applicable processes for certifications. Safety, privacy and security requirements are expected to lead the list. • Definition of interoperability and other applicable technology standards. • Clarification of how existing healthcare regulations, such as the Health Insurance Portability and Accountability Act (HIPAA) in the U.S., will affect certification. • Clarity on regulatory requirements for mHealth data traffic that crosses international boundaries. There are current regulations and guidelines in several regions that address requirements for mobile health. In addition, there are stakeholders around the globe advocating for a balance between patient safety and encouraging innovations. These efforts vary in effectiveness, and further work to establish successful mHealth regulations and guidelines is needed. European Union and Australia: guidelines with little clarity The European Union was probably the first to provide guidelines on mHealth applications and mobile apps, in January 2012. They focused on the “qualification and classification of standalone software used in healthcare within the regulatory framework of medical devices.”2 This guideline also covered applications on mobile devices. Since then, most of the member states of the EU have adopted these guidelines with necessary customizations, including U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA). Australia issued guidance on medical software and mobile medical apps through its regulatory agency TGA on September 13, 2013.3 These guidelines try to clarify how the existing rules for medical devices and drugs apply to software associated with medical devices, including mobile health applications. While the EU and Australian guidelines are a start, they are generic in nature and apply to any software associated with medical devices. mHealth apps are not specifically covered. The guidelines also lack depth and clarity and do not define all of the diverse and complex mobile health apps. The EU commission is now working on a green paper which will launch a public debate about using mHealth to take control of one’s health. They are also working on a guidance document on the legal framework applicable to health and wellness apps. The EU has indicated that it will issue the green paper and guidance document in early 2014. The USA: clearer guidelines, but further work is needed The FDA issued its final guidelines on mobile medical applications (MMAs) on September 25, 2013.5 These guidelines are the most descriptive thus far for mHealth apps. They are expected to help other countries define their own mHealth requirements and guidelines. Key highlights include: 1. The FDA is taking a tailored, risk- based approach that focuses on the small subset of mobile apps that meet the regulatory definition of device, and that either: –– Are intended to be used as an accessory to a regulated medical device, or –– Transform a mobile platform into a regulated medical device.
  4. 4. 4 2. The FDA will review only those mobile apps that have potential to harm the consumer. 3. The FDA will regulate both pure software that is used for some critical functions, as well as a combination of accessories and software that has the potential to harm the consumer. 4. The following are the type of mobile apps that the FDA considers to be mobile medical apps subject to regulatory oversight: –– Mobile apps that are an extension of one or more medical devices by connecting to such device(s) for purposes of controlling the device(s), or displaying, storing, analyzing or transmitting patient- specific medical device data. –– Mobile apps that transform the mobile platform into a regulated medical device by using attachments, display screens or sensors, or by including functionalities similar to those of currently regulated medical devices. –– Mobile apps that use attachments, display screens, sensors or other similar components to transform a mobile platform into a regulated medical device are required to comply with the device classification associated with the transformed platform. –– Mobile apps that become a regulated medical device (using software) by performing patient- specific analysis and providing patient-specific diagnosis or treatment recommendations. These types of mobile medical apps are similar to or perform the same function as those types of software devices that have been previously cleared or approved. 5. The FDA will apply the same risk- based approach used to assure safety and effectiveness for other medical devices. This includes: –– Regulating Class II (moderate-risk) and Class III (high-risk) MMAs –– Exercising enforcement discretion on lower-risk MMAs 6. The FDA will consider the applications on a case-by-case basis and will not require expensive, time-consuming clinical trials if the app resembles a medical device currently on the market. 7. The apps will be subject to the same regulatory standards that apply to the medical devices they resemble and not to any new set of standards. 8. The following are not regulated by the FDA: –– Mobile apps that do not meet the definition of device as defined by FDA — section 201(h) of the Federal Food, Drug, and Cosmetic Act –– Electronic medical record, electronic health record and personal health record apps on mobile devices –– Mobile devices –– Mobile apps store –– Mobile platform manufacturer While these guidelines serve as good starting points, there are still many unanswered questions. The FDA has said that it will submit a report to the U.S. Congress in early 2014 that outlines a broad framework for health IT regulation. The FDA says this report will describe how these mHealth guidelines will work. This should help clarify the future regulatory environment for mHealth.
  5. 5. 5 International group working on recommendations In addition to these attempts at defining mHealth regulatory frameworks in the USA, the EU and Australia, a global group of device regulators is developing a set of recommendations that would establish international standards for medical apps. The International Medical Device Regulators Forum (IMDRF) is a voluntary association of medical device regulators from around the world — including those from Australia, Brazil, Canada, EU, Japan and USA.7 The IMDRF formed a dedicated working group in March 2013, tasked with developing and harmonizing approaches to the regulation of standalone medical device software, including MMAs. Once the group’s recommendations are available, the IMDRF expects that many of the member agencies and others will update their existing guidelines and regulations to meet these standards or adopt the IMDRF standards as their own. Advocacy efforts focus on balance between safety and innovation While regulators are drafting standards, industry forums, not-for-profit organizations and policy makers are advocating for regulations that create an environment which protects patient safety and privacy without setting up barriers that will discourage innovation. mHealth Regulatory Coalition The mHealth Regulatory Coalition (MRC) is a Washington-based advocacy group established in 2010 with the sole purpose of making sure the regulatory environment around mHealth technologies does not limit innovation. MRC brings together a broad group of stakeholders in mHealth, including app developers, cellular handset manufacturers, network operators, healthcare providers, researchers, and patient and disease-focused advocacy groups. MRC played a key role in moving the FDA to publish its mHealth guidelines ahead of the originally proposed release date of January 2014. MRC is now working on issues concerning the published guidelines. Its activities include: • Defining which agency should regulate mHealth • Clarifying the scope of the FDA’s regulatory powers • Improving the regulatory environment for apps subject to FDA oversight MRC has now formed a European equivalent of the American group, called MRC EU. It expects to go country by country to address the regulation of standalone medical software and mobile medical apps. Other advocacy groups The mHealth Alliance is a voluntary organization hosted by the United Nations Foundation. It was founded in 2009 by the Rockefeller Foundation, the Vodafone Foundation and the UN Foundation with a mission “to harness the power of wireless technologies to improve health outcomes in low and middle income countries.” It advocates for establishing standardization and interoperability of mHealth platforms. In addition to its original founding partners, it now lists HP, GSM Association and the Norwegian Agency for Development Cooperation (Norad) as founding partners. D4 is a voluntary organization in the U.K. that promotes mobile health technology adoption by healthcare professionals. They also advocate for balanced mHealth regulations. U.S. legislative efforts to promote predictability and limit FDA oversight Representative Mike Honda, (D-CA), has proposed establishing an Office of Wireless Health in the FDA through legislation called the Healthcare Innovation and Marketplace Technologies Act (HIMTA). Originally introduced in 2012 and reintroduced in June 2013, the act proposes establishment of this new office. It aims “to cultivate a predictable regulatory framework on wireless health issues, as well as develop a mHealth support program at the Department of Health and Human Services to help mobile health app developers conform to current privacy standards.” Representative Marsha Blackburn (R-TN), leading a group of bipartisan law makers, introduced the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act of 2013. Its intent, according to Blackburn, is to provide regulatory clarity on mobile medical applications, clinical decision support, electronic health records and other health-related software. It also seeks to ensure regulatory restraint and limit the FDA’s powers. The act defines three categories of mHealth software: medical, clinical and health. Under the proposed act, only medical apps would need FDA approval. The act defines medical apps as software that directly changes the structure or functioning of the body (or would do so if its recommendations or diagnostic findings were followed), or includes the use of a regulated therapy without physician involvement. Emerging clarity on regulations fueling innovation and uptake Clearly, advocacy efforts are gaining momentum across the globe, as are efforts to define appropriate regulations and guidelines for mHealth. Healthcare providers, health IT vendors, regulators, governments, non-governmental organizations (like the UN and the World Healthcare Organization), cellular manufacturers, network operators, researchers, patients and disease-specific support groups have all been part of this process. Thanks to their efforts, by the end of 2014 or in early 2015, the mHealth regulatory landscape is likely to be much more defined and predictable, at least in the developed world. With this increased regulatory clarity, developers will move forward on
  6. 6. 6 affordability, reach and availability issues. The following are some of the key developments we predict will occur in the near future. Demand for mHealth applications will increase as healthcare providers, payers and life sciences organizations accelerate adoption of mobile tools. Innovation will increase as regulatory clarification creates the predictability needed to encourage investors and entrepreneurs. Payers will reimburse for services provided through mobile medical apps. In fact, payers will encourage adoption of telehealth as a means of increasing access to care and lowering costs. For example, Medicare, the government- funded health insurance program for the elderly and disabled in the U.S., has just announced the expansion of coverage for telehealth consults in 2014. The Internet of Things will grow. Regulatory clarity will encourage developers, and there will be an exponential increase in the number of web-enabled medical devices in the next few years. This will increase the number of “things” communicating via the internet. The Internet of Things and machine to machine technologies are catching up in a big way and mHealth is the gateway to its adoption in healthcare. New ancillary industries will grow. This includes: • Mobile-based personal health monitoring will go beyond fitness apps. Smart phones, phablets (hybrid devices that are tablets with phone capabilities) and tablets designed for medical use will make their way into the market. Accessories will become available for wireless tracking of vital signs that go beyond measuring heart rate to include a wide range of health metrics. • Remote health monitoring and interventions will increase. Home monitoring systems will increase due to hospitals seeking to prevent unnecessary readmissions and physicians seeking to improve outcomes for patients with chronic diseases and unstable or fragile conditions. The need to serve patients in medically underserved areas of the globe will spur development of a wide variety of telehealth systems that use remote monitoring devices. • Non-traditional players will enter the market to provide remote health services. Telecommunications players will invest in mHealth initiatives leading to further innovation and reach. Let the preparations begin Despite a wide variety of regulatory environments and differences in health systems, a kind of globalized regulation is shaping up for mHealth, which is quite an interesting phenomenon for a globally diverse industry like healthcare. This will allow mHealth applications to function across national borders, while remaining locally relevant and locally regulated. To prepare for the coming expansion of mHealth in the wake of this new regulatory clarity, stakeholders should take the following steps now: • If you have mobile apps that are already being used or under development, consider a quick audit using published FDA guidelines and local regulatory compliance (where available) — and take action accordingly. • Revisit your mobility strategy and redefine goals and objectives to make sure regulatory requirements are incorporated appropriately into your initiatives. Evaluate your portfolio of mobility initiatives in the pipeline using FDA and local guidelines wherever available. • Update telehealth and medical home programs with mHealth regulation audits built in. • Keep an eye on local regulatory bodies to make sure you know about any new guidelines or updates to existing regulations. • If your organization is operating in more than one country, audit your apps and devices to ensure they meet the regulatory requirements for each country in which they will be marketed. Make sure that your apps also comply with country- specific security and privacy laws, since most of the regulations are likely to refer to these. • Work with your vendors and mHealth app providers (IT/Devices/ Drugs) to ensure all devices and apps they provide are approved by the FDA as well as local regulators. If the FDA model becomes universal, having FDA-approved devices and apps will simplify the approval process. • Ensure that your bring-your-own- device (BYOD) strategies take regulatory requirements into consideration.
  7. 7. This white paper is for information purposes only, and may contain typographical errors and technical inaccuracies. The content is provided as is, without express or implied warranties of any kind. Product and service availability varies by country.  To learn more, customers and Dell Channel Partners should contact their sales representative for more information.  Specifications are correct at date of publication but are subject to availability or change without notice at any time.  Dell and its affiliates cannot be responsible for errors or omissions in typography or photography.  Dell’s Terms and Conditions of Sales and Service apply and are available on request.  Dell and the Dell logo are trademarks of Dell Inc.  Other trademarks and trade names may be used in this document to refer to either the entities claiming the marks and names or their products.  Dell disclaims proprietary interest in the marks and names of others.  © 2014 Dell Inc.  All rights reserved. March 2014 | D388 - mHealth Regulations white paper.indd | Rev. 1.0 Scan or click this code to learn how Dell Services can help your organization. As the rapid spread of mHealth continues, a regulated environment will become a necessity. In most cases, these regulations are expected to have significant commonalities across the globe, in addition to local flavor. While there are issues that need to be sorted out on who regulates, what is regulated and how it is regulated, the FDA guidelines on mHealth have helped fill a considerable portion of the regulatory vacuum at a global level. mHealth regulatory agencies and legislators, in response to active advocacy by the industry and end users, are shaping regulatory policy to ensure innovation is not hampered by the need for patient safety. The pressure on governments to come up with better and more balanced legislation and guidelines on mHealth is constant. This will push countries which have previously been very passive, such as China and India, to act on the much-awaited regulations governing mHealth. Establishing a pro-innovation regulatory environment is critical to fueling innovation in mHealth to address cost and quality of care — both crucial priorities in healthcare. For more information about any of our services or solutions, please visit Dell.com/healthcare or contact your Dell representative. Written by: Dr. Sandesh R. Prabhu, MBBS, MBA, Professional, Academy for Healthcare Management Healthcare Solution Strategist, Business Innovation Services, Dell 1 2013 Mobile Trends Report 2 Guidelines on the qualification and classification of stand-alone software used in healthcare within the regulatory framework of medical devices (EMA, MEDDEV 2.1/6, 2012) 3 Regulation of medical software and mobile medical ‘apps’ (TGA Guidance, 13 September 2013) 4 EU regulation of mHealth by Erik Vollebregt (Chapter XV., FDA regulation of mHealth, Second Edition, Pub. By Chester Street Publishing Inc., 2013) 5 Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff (25 September 2013) Conclusion
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