F.D.A. to Regulate Some Health Apps

September 24, 2013 Leave a comment

September 23, 2013

F.D.A. to Regulate Some Health Apps

By SABRINA TAVERNISE

The Food and Drug Administration said Monday that it would regulate only a small portion of the rapidly expanding universe of mobile health applications, software programs that run on smartphones and tablets and perform the same functions as medical devices. Agency officials said their goal is to oversee apps that function like medical devices, performing ultrasounds, for example, and that could potentially pose risks to patients. Tens of thousands of health apps have sprung up in recent years, including apps that count steps or calories for fitness and weight loss, but agency officials said they would not regulate those types of apps.Some apps have already gotten the agency’s stamp of approval. One turns a phone paired with a special case into a portable electrocardiogram machine. Others make a phone double as an ultrasound device or a tool for measuring a person’s glucose levels.

“We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly,” said Dr. Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health.

The agency’s decision to specify the regulatory rules is likely to spur the innovation of apps that perform medical functions, said Dr. Joseph M. Smith, chief medical and science officer at West Health Institute, a nonprofit medical research organization. He said the development of such apps had been slow, in part because of a lack of clarity about how the agency would treat them.

“This is very welcome news for the innovator and investment community,” Dr. Smith said.

The agency will consider the apps case by case and will not require expensive, time-consuming clinical trials if the app resembles a medical device currently on the market. The apps will be subject to the same regulatory standards that apply to the medical devices they resemble.

The agency has cleared about 100 mobile medical apps in the past decade, about 40 of them in the past two years. None of them were required to go through costly regulatory hurdles like clinical trials.

Filed under Health, TMT Trends

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Kee Koon Boon (“KB”) is the co-founder and director of HERO Investment Management which provides specialized fund management and investment advisory services to the ARCHEA Asia HERO Innovators Fund (www.heroinnovator.com), the only Asian SMID-cap tech-focused fund in the industry. KB is an internationally featured investor rooted in the principles of value investing for over a decade as a fund manager and analyst in the Asian capital markets who started his career at a boutique hedge fund in Singapore where he was with the firm since 2002 and was also part of the core investment committee in significantly outperforming the index in the 10-year-plus-old flagship Asian fund. He was also the portfolio manager for Asia-Pacific equities at Korea’s largest mutual fund company. Prior to setting up the H.E.R.O. Innovators Fund, KB was the Chief Investment Officer & CEO of a Singapore Registered Fund Management Company (RFMC) where he is responsible for listed Asian equity investments. KB had taught accounting at the Singapore Management University (SMU) as a faculty member and also pioneered the 15-week course on Accounting Fraud in Asia as an official module at SMU. KB remains grateful and honored to be invited by Singapore’s financial regulator Monetary Authority of Singapore (MAS) to present to their top management team about implementing a world’s first fact-based forward-looking fraud detection framework to bring about benefits for the capital markets in Singapore and for the public and investment community. KB also served the community in sharing his insights in writing articles about value investing and corporate governance in the media that include Business Times, Straits Times, Jakarta Post, Manual of Ideas, Investopedia, TedXWallStreet. He had also presented in top investment, banking and finance conferences in America, Italy, Sydney, Cape Town, HK, China. He has trained CEOs, entrepreneurs, CFOs, management executives in business strategy & business model innovation in Singapore, HK and China.

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