FDA Guidance for Mobile Medical Applications

The widespread adoption and use of mobile technologies is opening new and innovative ways to improve health and health care delivery.

Mobile applications (apps) can help people manage their own health and wellness, promote healthy living, and gain access to useful information when and where they need it. These tools are being adopted almost as quickly as they can be developed. According to industry estimates, 500 million smartphone users worldwide will be using a health care application by 2015, and by 2018, 50 percent of the more than 3.4 billion smartphone and tablet users will have downloaded mobile health applications. These users include health care professionals, consumers, and patients.

The FDA encourages the development of mobile medical apps that improve health care and provide consumers and health care professionals with valuable health information. The FDA also has a public health responsibility to oversee the safety and effectiveness of medical devices – including mobile medical apps.

The FDA issued the Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff on September 25, 2013, which explains the agency’s oversight of mobile medical apps as devices and our focus only on the apps that present a greater risk to patients if they don’t work as intended and on apps that cause smartphones or other mobile platforms to impact the functionality or performance of traditional medical devices.

What are mobile medical apps?

Mobile apps are software programs that run on smartphones and other mobile communication devices. They can also be accessories that attach to a smartphone or other mobile communication devices, or a combination of accessories and software. 

Mobile medical apps are medical devices that are mobile apps, meet the definition of a medical device and are an accessory to a regulated medical device or transform a mobile platform into a regulated medical device.

Consumers can use both mobile medical apps and mobile apps to manage their own health and wellness, such as to monitor their caloric intake for healthy weight maintenance. For example, the National Institutes of Health’s LactMed app provides nursing mothers with information about the effects of medicines on breast milk and nursing infants.

Other apps aim to help health care professionals improve and facilitate patient care. The Radiation Emergency Medical Management (REMM) app gives health care providers guidance on diagnosing and treating radiation injuries. Some mobile medical apps can diagnose cancer or heart rhythm abnormalities, or function as the “central command” for a glucose meter used by an insulin-dependent diabetic patient.

How will the FDA regulate mobile medical apps?

The FDA will apply the same risk-based approach the agency uses to assure safety and effectiveness for other medical devices.  The guidance document provides examples of how the FDA might regulate certain moderate-risk (Class II) and high-risk (Class III) mobile medical apps. The guidance also provides examples of mobile apps that are not medical devices, mobile apps that the FDA intends to exercise enforcement discretion and mobile medical apps that the FDA will regulate in Appendix A, Appendix B and Appendix C.

We encourage app developers to contact the FDA – as early as possible – if they have any questions about their mobile app, its level of risk, and whether a premarket application is required.

Mobile medical apps that the FDA will regulate

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:

• are intended to be used as an accessory to a regulated medical device, or
• transform a mobile platform into a regulated medical device. 

Mobile apps span a wide range of health functions. While many mobile apps carry minimal risk, those that can pose a greater risk to patients will require FDA review.

Please visit the mobile medical apps example page for a list of examples of mobile medical apps that have been cleared or approved by the FDA. Visit the Examples of MMAs the FDA regulates webpage for a more detailed list of examples of mobile apps that would require FDA review.

For a list of what is considered a mobile medical application, manufacturers and developers of mobile applications can search FDA’s database of existing classification by type of mobile medical application  (for example diagnostic).  Approved/cleared mobile medical applications will also be listed in FDA’s 510(k) and PMA databases and on the FDA’s Registration & Listing Database. 

FDA’s mobile medical apps policy does not require mobile medical app developers to seek Agency re-evaluation for minor, iterative product changes.

Mobile apps for which the FDA intends to exercise enforcement discretion

For many mobile apps that meet the regulatory definition of a “device” but pose minimal risk to patients and consumers, the FDA will exercise enforcement discretions and will not expect manufacturers to submit premarket review applications or to register and list their apps with the FDA. This includes mobile medical apps that:

• Help patients/users self-manage their disease or condition without providing specific treatment suggestions;
• Provide patients with simple tools to organize and track their health information;
• Provide easy access to information related to health conditions or treatments;
• Help patients document, show or communicate potential medical conditions to health care providers;
• Automate simple tasks for health care providers; or
• Enable patients or providers to interact with Personal Health Records (PHR) or Electronic Health Record (EHR) systems.

Does the FDA regulate mobile devices and mobile app stores?

FDA’s mobile medical apps policy does not regulate the sale or general consumer use of smartphones or tablets. FDA’s mobile medical apps policy does not consider entities that exclusively distribute mobile apps, such as the owners and operators of the “iTunes App store” or the “Google Play store,” to be medical device manufacturers. FDA’s mobile medical apps policy does not consider mobile platform manufacturers to be medical device manufacturers just because their mobile platform could be used to run a mobile medical app regulated by FDA.

Does the guidance apply to electronic health records?

FDA’s mobile medical app policy does not apply to mobile apps that function as an electronic health record (EHR) system or personal health record system.

For more information please check following link:

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf

mHealth in India - 3000 Crores INR opportunity by 2017: PwC

‘Touching Lives through Mobile Health: Assessment of the Global Market Opportunity’ report, conducted by PwC for the GSMA, mobile technology will play a significant role in the provision of healthcare services globally. It also predicts that the growth of the mHealth market will lead to a revenue opportunity worth Rs. 3000 crores (US $ 0.6 billion) for India and US$23 billion for the world by 2017. The report also examines the key challenges the healthcare industry is facing worldwide and the opportunity which mobile technology provides in overcoming these challenges.

India has witnessed significant activity in the mobile health space with the launch of several different services, however the majority of initiatives are focused on spreading prevention and awareness messages. According to the report, the Mobile Health market opportunity for India will constitute 8% of the total Asia-Pacific opportunity in 2017.

In India, rapid mHealth adoption is likely to occur before widespread eHealth. Today, only 3% of households have a computer with internet access, while 69% of Indian households have a mobile phone. Smartphone adoption has increased dramatically in recent years with shipments growing by 167% in 2013.Leading operators are beginning to offer 3G and 4G services at affordable price points. These factors are likely to both spur data usage and drive the adoption of mHealth services.

Traditionally, healthcare systems are viewed as the “iron triangle” of access, quality and cost. No one factor can change without affecting another. Improving access or quality requires increased investment, and lowering costs will either affect quality or access. In India, mHealth is one of the disruptive technologies that can sever the iron triangle by increasing access, improving quality and lowering costs for all of its market segments.


Commenting on the findings of the report Mohammad Chowdhury, Telecoms Industry Leader, PwC India said, “Our estimates suggest that in spite of the advancements in medical technologies and a general increase in income levels, healthcare continues to pose challenges of affordability, complexity and access across the whole world. By contrast, mobile access is almost ubiquitous. With the increasing penetration of smart phones,  innovative ‘connected devices’, and the proliferation of  Mobile Broadband networks and services worldwide,  the mobile device will play a far greater role in healthcare in both developed and developing countries in the future”.

To enable this opportunity, governments, regulators and healthcare providers need to work with mobile operators and organisations in the broader mHealth ecosystem, including device vendors and content and application players, to support the roll-out and adoption of new mHealth services.

PwC sees four scaling factors as being critical to seeing m-health make a significant impact on society, as follows:

• Government: Only when governments worldwide embrace constructive policy agendas for mHealth will the market start to achieve its potential and scale rapidly. Governments should take steps to adopt the concept of mHealth as an effective way to improve access to and affordability of healthcare. This includes encouraging the use of mHealth services by public healthcare providers and incentivising private providers to deliver mHealth services.
• Regulatory: Regulators need to proactively address the issues that currently limit the growth of mHealth services, certification, interoperability and standardisation.
• Healthcare industry: Clear benefit studies from key players in the mHealth ecosystem, as well as government support, are vital to driving acceptance in the medical profession.
• User adoption: Widespread user adoption will help drive the exponential growth and market opportunity for mHealth. This will be supported by recommendations from medical professionals, overall service affordability and widespread availability of content and devices.

“While the opportunity for mHealth services in India as well as globally is huge, for it to fall into place and become an effective tool of social inclusion the government and the entire healthcare ecosystem will have to work together even as they compete on other fronts so that the benefits percolate to the segment which most requires it. Favourable government policies and regulatory regimes will be crucial for scaling up mobile health,” stated Siddharth Vishwanath, executive director, PwC India.

Few highlights of the report are:

• Europe to become the largest mHealth region by 2017 with revenues of US$6.9 billion. Asia Pacific would be the second-largest region with revenues of US$6.8 billion, North America could account for US$6.5 billion, Latin America US$1.6 billion and Africa US$1.2 billion.
• In terms of individual countries, the United States could benefit from revenues of US$5.9 billion, accounting for a quarter of the global mHealth market by 2017, and revenues in China and Japan could reach US$2.5 billion and US$1.4 billion respectively.
• Monitoring services, such as those for chronic disease management, will account for 65 per cent of the market (US$15 billion) by 2017.
• Diagnosis services will be the second-largest segment, comprising 15 per cent of the global mHealth market (US$3.4 billion). This includes mobile telemedicine and health call centres that allow those in isolated areas to connect with healthcare professionals.

For details please check following link:

http://www.gsma.com/connectedliving/wp-content/uploads/2012/03/gsmapwctouchinglivesthroughmobilehealthreport.pdf

mHealth - Pregnancy & Childbirth

Each year, approximately 350,000 women around the world die unnecessarily as a result of preventable causes related to pregnancy and childbirth. Half of the 7.5 million deaths among children under five years of age occur during the first 28 days of life, also from largely preventable causes. These deaths occur primarily in the Global South – in sub-Saharan Africa and South Asia.
Cell phones could be saving their lives.

Mobile Technology Is Everywhere

In a world with 7 billion people, 6 billion of them are mobile phone subscribers.  A new report “Leveraging Mobile Technologies to Promote Maternal and Newborn Health,” found that combining mobile technologies with existing health system resources would provide women and newborns with:

Timely interventions that promote decisions to seek care and stimulate demand for available services– such as text messages that provide health education and increase awareness of health resources; Improved access to health services and facilities, for example through services that equip community-based health workers with mobile tools, extending health coverage into households and the community; and Health care that is delivered efficiently and expertly, through communication services that connect women to peer networks or local expert resources. Mobile technologies are rapidly expanding throughout the world. The question is whether we can harness these technologies to impact the health and lives of women and children ("mHealth"), particularly in the Global South.



New mHealth tools are emerging, including:

mCheck, which helps women in India identify health risks in the first week after delivery and seek treatment;
Cellphones4HIV in South Africa, which aims to prevent the transmission of HIV/AIDS from mother to child through text messages with educational messages and reminders for appointments, tests and treatment; and,
Mi Bebe, which enables health workers to monitor women with high-risk pregnancies remotely to provide early warning of abnormalities and refer them to treatment in a timely way. So, how do we make sure every mobile user can access these kinds of tools? 



Bringing mHealth to the broader public

Currently, mHealth applications for maternal and child health are in the formative design and test stages of implementation. As a result, evidence of their effectiveness is only now emerging. It is critical that we develop and implement more rigorous evaluation of mHealth tools currently in place. If these are shown to positively impact maternal and child health, we also need to make sure we can bring these tools to those countries, cities, and towns that need them most.

We cannot look at mHealth technology in a technology vacuum, though. For us to take it to scale in the places worldwide where it is most needed, we will have to address many other related issues, such as social factors, strategic partnerships and business models. For example, by addressing social factors like literacy and inequities in women’s access to mobile phones, we can remove barriers that impede the reach of mHealth services. We can also adapt services to meet user needs—such as using voice messaging instead of text messaging where literacy is low. Helping to remove barriers to using the technology will ultimately lead to broader adaptation and better health outcomes.

Innovation will also need to be flexible and adaptable to the quickly evolving nature of technology, and build on existing information and communication technology capabilities. We don’t need to reinvent the wheel.

mHealth - Connected Healthcare - Reduces costs, Increases Accessibility

mHealth (mobile health) is a general term for the use of mobile phones and other wireless technology in medical care.


Embedded mHealth solutions can improve the lives of millions of people and help address some of the most significant healthcare challenges in the world today. One of the biggest challenges facing societies worldwide is how to make high-quality healthcare affordable and accessible for all. As the population expands in developing countries and ages in developed countries, the world is spending an increasingly high proportion of its gross domestic product on healthcare.Governments, individuals and private insurers worldwide are urgently seeking more cost-effective ways of preventing and treating chronic diseases and other debilitating conditions.The widespread use of mobile connectivity in healthcare could significantly cut costs, increase the reach and accessibility of healthcare services and reduce the impact of illness on people's lives. To accelerate the development and adoption of embedded mHealth devices and solutions, the GSMA is engaging with the wider ecosystem and working with key players to understand their needs and to reduce the barriers to adoption.

The most common application of mHealth is the use of mobile phones and communication devices to educate consumers about preventive health care services. However, mHealth is also used for disease surveillance, treatment support, epidemic outbreak tracking and chronic disease management. mHealth is becoming a popular option in underserved areas where there is a large population and widespread mobile phone usage. 

Embedded mHealth solutions can improve the lives of millions of people and help address some of the most significant healthcare challenges in the work today. The world is already spending around US$ 6 trillion each year on healthcare. 

By 2030, the World Diabetes Foundation estimate 438 million people, approximately 7.8% of the adult population, will live with diabetes; mobile delivers the opportunity to help them manage their disease and ultimately help reduce the spiraling costs of chronic disease management. 

It is estimated that $175-$200 billion in chronic disease management costs could be saved each year by remote monitoring solutions. Mobile health solutions provide a real opportunity to help healthcare providers deliver better, consistent and more efficient care, and to empower individuals to manage their own health more effectively.

The mHealth solutions bring the following benefits:

For patients and society:

• Automatic health monitoring
• Prevention through continuous care and lifestyle coaching
• Better and faster treatment
• Elderly and ill can live at home rather than in a nursing home or hospital
• Greater life expectancy
• Fewer absences from work
• Lower health insurance premiums and lower public spending on healthcare

For healthcare providers:

The mHealth Grand Tour is looking to help stimulate innovation and demonstrate how solutions can help in the prevention and management of diseases.

• Fewer hospital visits and more efficient use of clinicians' time
• Earlier intervention enabling better and more cost-effective treatment
• Access to more and better information about a patient's condition and lifestyle
• Improved communications with patients
• Better management and understanding of epidemics and disease

While others exist, the UN Foundation and Vodafone Foundation report presents seven application categories within the mHealth field.

• Education and awareness
• Helpline
• Diagnostic and treatment support
• Communication and training for healthcare workers
• Disease and epidemic outbreak tracking
• Remote monitoring
• Remote data collection

Emerging trends and areas of interest in mHealth

• Emergency response systems (e.g., road traffic accidents, emergency obstetric care)
• Human resources coordination, management, and supervision
• Mobile synchronous (voice) and asynchronous (SMS) telemedicine diagnostic and decision support to remote clinicians
• Clinician-focused, evidence-based formulary, database and decision support information available at the point-of-care
• Pharmaceutical Supply Chain Integrity & Patient Safety Systems (e.g. Sproxil and mPedigree)
• Clinical care and remote patient monitoring
• Health extension services
• Health services monitoring and reporting
• Health-related mLearning for the general public
• Training and continuing professional development for health care workers 
• Health promotion and community mobilization
• Support of long-term conditions e.g. diabetes self-management
• Peer-to-Peer Personal Health Management, for telemedicine