Telecare Sector Set For Growth As FDA Issues Guidance For App Developers


Espicom View: Mobile medical apps have the potential to transform healthcare in both developed and emerging markets. While healthcare systems in developed markets can employ telecare technology to improve workflow efficiency, health systems in emerging regions can utilise the technology to provide healthcare to patients who would otherwise be deprived. Additionally, the growth in the number of smartphone users worldwide, coupled with advances in the application of communication technology to address health priorities, could provide significant opportunities for companies looking to invest in the telecare sector.

Mobile medical applications (apps), software programs that run on mobile communication devices and perform the same functions as traditional medical devices, can help people manage their own health, promote healthy living and gain access to medical information on demand. The recent global uptake of these apps has meant that they are being adopted almost as quickly as they can be developed. According to the FDA and industry estimates, 500mn smartphone users worldwide will be using healthcare apps by 2015, and by 2018, 50% of the more than 3.4bn smartphone and tablet users will have downloaded mobile medical apps.

The FDA is keen to encourage the development of mobile medical apps, but has a public responsibility to oversee the safety and effectiveness of this new class of medical device. As a result, the Agency has issued final guidance for developers of mobile medical apps, outlining a tailored approach.

The FDA intends to exercise enforcement discretion, meaning it will not enforce requirements under the Federal Drug & Cosmetic Act, for the majority of mobile apps, as they pose minimal risk to consumers. The Agency intends to focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended.

Mobile medical apps have the potential to transform healthcare by allowing doctors to diagnose patients with potentially life-threatening conditions outside of traditional healthcare settings, help consumers manage their own health and wellness, and also gain access to useful information whenever and wherever they need it. Mobile medical apps currently on the market can, for example, diagnose abnormal heart rhythms, transform smartphones into a mobile ultrasound device, or function as the 'central command' for a glucose meter used by a person with insulin-dependent diabetes.

The FDA is focusing its oversight on mobile medical apps that:

• are intended to be used as an accessory to a regulated medical device, for example, an app that allows a healthcare professional to make a specific diagnosis by viewing a medical image from a PACS on a smartphone or a mobile tablet; or

• transform a mobile platform into a regulated medical device, for example, an app that turns a smartphone into an ECG machine to detect abnormal heart rhythms or determine if a patient is experiencing a myocardial infarction.

Mobile medical apps that undergo FDA review will be assessed using the same regulatory standards and risk-based approach that the Agency applies to other medical devices. The FDA does not regulate the sale or general consumer use of smartphones or tablets, nor does it regulate mobile app distributors.

The FDA received more than 130 comments on its draft guidance, which was issued in July 2011. According to the Agency, respondents overwhelmingly supported the tailored, risk-based approach. The FDA had cleared around 100 mobile medical apps over the past decade; approximately 40% of which were cleared in the past two years.

According to Business Monitor International, global healthcare spending reached US$7,132bn in 2012, and is forecast to reach US$9,081bn by 2017. Additionally, BMI has identified 6.5bn mobile phone subscribers worldwide in 2012, and by 2017, this is forecast to increase to 8.1bn subscribers. In emerging markets in particular, governments are adopting telecare as a complementary strategy for strengthening healthcare systems and increasing populations' access to healthcare. In developed markets, governments are employing telecare to improve healthcare delivery, with a view to reducing the burden on national health services and public finances.

A number of multinational healthcare companies, including GE Healthcare, Philips, Johnson & Johnson and Abbott, have produced apps for use by patients and healthcare professionals. These apps include disease calculators, educational packges, health monitors, medication schedules and test kits. Sanofi became the first healthcare company to develop a glucose meter that attaches directly to a smartphone, allowing the user to track and share their glucose levels and trends. Developed markets, such as Japan, Western Europe and North America, currently offer the greatest opportunities for companies looking to benefit from the expected growth in self-care services. These services are expected to be largely consumer driven, and BMI expects uptake to be highest in markets where subscribers are used to purchasing apps for their smartphones for a variety of services.

Within emerging markets, Russia and Brazil are also predicted to experience growth in mobile medical apps, in major cities such as Moscow and St Petersburg in Russia and Brazil's São Paulo, Rio de Janeiro and Curitiba; these areas contain large affluent populations whose spending and telecoms usage habits reflect those seen in more developed markets. Less developed markets may see the development of apps specifically designed for their regions. An example of this is the Mimba Bora pregnancy app, which was developed by a software provider specifically for the Kenyan market. The app allows parents to monitor pregnancies week by week.

The FDA has already approved a number of mobile medical apps in the US, such as diabetes management systems, blood pressure monitors and arrhythmia detectors. With the Agency's final guidance published, it is likely that many healthcare companies, large and small, will now be recognising the huge opportunity in investment in telecare. Additionally, with the FDA's pro-active attitude toward the development of mobile medical apps, further healthcare regulatory bodies worldwide may now follow suit, and issue their own guidelines to monitor the development of apps, which, in turn, will fuel development and global uptake of the technology.

This article is tagged to:
Sector: Medical Devices
Geography: Global, United States