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Remote Monitoring – Can You Handle It?

8 Oct 2014 by Stephen Siciliano

In 2010, when Eric Topol, then the director of Scripps Transnational Science Institute and Scripps Health, predicted that hospitals would be replaced by wireless technologies tracking the health of “digitized man,” his optimism seemed to some like classic California New Age-speak.

Today, Topol is the new chief medical adviser for AT&T; a company that knows a little something about remote communication.

In 2013, Kentucky-based Humana announced three collaborations on pilot programs with Valued Relationships, Inc., AMC Health, and Healthsense. These programs addressed such disparate conditions as congestive health failure, seniors falling at home, and an “activities of daily living” in-home pilot, respectively.

The numbers involved are impossible to ignore. Humana Cares/Senior Bridge, the company’s chronic care management division, supports over 400,000 patients.

Clearly, telehealth and remote monitoring are here to stay.

The Obama Administration, for its part, claims that it is trying to stay out of the way where the regulation of health information technologies is concerned. Guidelines released by the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health appear to err on the side of restricting regulation to products that pose “serious” safety risks in the event of a failure, or patient misuse. The guidelines would limit the FDA’s authority to mobile medical apps that transform mobile platforms into medical devices and accessories that act in the same way as devices/accessories already regulated by the federal government.

Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, has said that the “mobile apps guidance” label is something of a misnomer, because it’s aimed at the functions products perform, rather than the platform itself.

At the legislative level, Reps. Doris Matsui (D-CA) and Bill Johnson (R-OH) have concocted that rare animal: a bi-partisan bill that defines telehealth as the provision of medical services in locations; distinct from the professional delivering care in accordance with state laws.

The legislators hope the measure provides the states guidance on how to develop policies that jibe with other states, so that care can be delivered seamlessly across the country.

Telehealth advocates still seek a national standard to replace the patchwork of state laws governing remote services and technologies that make it difficult for caregivers to understand the distinct requirements in each jurisdiction.

A 2013 study by Kalorama Information revealed impressive growth in patient monitoring. The United States market saw revenue of $4 Billion in 2007; a figure that jumped to $10.6 Billion in 2012 and which the research outfit predicted will reach $20.9 Billion by 2016.

But for all the pilots, revenue growth and legislative attempts to create a unified market for telehealth and remote monitoring, widespread use, Kalorama said, “is still years away” from becoming part of standard care pathways.

According to the technology titan Cisco, the majority of mobile apps on personal devices are for exercise and healthy eating. Just 25 percent report the use of mobile apps for the management of chronic diseases.

The Challenges of App-Based Healthcare

One small research effort, published in the journal “Telemedicine and e-Health” last year, found that 53 percent of those in the study group preferred in-office visits to remote interactions.

An enormous challenge in our hacker-laced cyber-environment remains ensuring that information transmitted from patient monitors to caregivers is secure, in particular the volumes of data sent from patient monitors to cloud-based data-warehouse systems via cell networks.

The telemedical market must also resolve whether open source or proprietary operating systems best meet security requirements for remote patient monitoring.

Those who enjoy the price of open source systems (free!), their free development tools and access to a wide range of software developers, are finding it difficult to meet regulatory and certification requirements without inadvertently getting into the operating system business themselves. Overhead can grow quickly.

Some proprietary systems, by contrast, have achieved compliance with the international standard (IEC 62304), which is harmonized by the European Union and the U.S. and specifies life-cycle requirements for medical device software. These, of course, you must pay for.

Other issues include which treatments are best-suited to remote interaction and which are still best served through traditional, face-to-face examination.

Concerns remain that doctors who commit malpractice, but are based out-of-state, may not be held accountable. Some believe physicians providing care from another jurisdiction must still be required to meet certification standards in the place where their patient lives.

Fragmentation is the general impediment as we move forward into this new world of mobile medical apps; and integration — through elusive, unified platforms — remains the Holy Grail.