Mobile Healthcare Trends

Doctors love their iPads and their iPhones: 87% of providers use mobile devices in their workplace for communications, access to information sources and to run clinical software applications.1 This trend is a boon for healthcare innovation. With such wide spread use, mobile devices are a ready-made platform for modernizing patient-provider communications, provide-to-provider consultations and more.

Shave Critical Minutes
Stroke care is a race against time. A stroke comes on quickly and effective stroke treatments need to be administered within a three-hour window. In the “stroke belt,” an area of high-stroke mortality which extends across the southeastern U.S. as far western Texas, stroke mortality is 40% higher than the rest of the country. Why? In this part of the country, most patients live far enough from a primary stroke center to make timely care a critical issue.

Telestroke, a telehealth application that is revolutionizing stroke care by bringing the expertise of stroke specialists to small rural and community hospitals. Instead of spending time transporting a patient to the physical location of the specialist, telestroke connects the specialist to rural providers using real-time image-viewing and video communications. With access to patient images and input from the provider treating the patient, the remotely located specialist can diagnose and recommend treatment from a distance. Telestroke supports faster, more accurate diagnosis and quicker treatment that saves lives.

This life-saving impact is driving adoption of telestroke. In a 2013 survey, almost 7% of hospitals reported using telestroke which is a high rate of use for a telehealth application.2 As Lee Schwamm, vice chair of the Department of Neurology at Massachusetts General Hospital in Boston noted in iHealthBeat, “Telestroke is the poster child of telemedicine. It’s a really nice example of where the business case is so evident and the benefit to patients is well-documented.”3

Today, not only do specialists have access to those scans remotely, they can view them and make a diagnosis from a mobile device, further transforming stroke patient care.

“When I’m called in on stroke cases, I run from the parking lot to the ER,” explains Michael Hill, MD and professor of clinical neurosciences, community health sciences, medicine and radiology at the University of Calgary. Using a tablet or smartphone, providers like Hill can shave even more time off the lapse between symptom onset and treatment. They can view images from wherever they are, either within or outside the four walls of a hospital system, giving them access to patient images with virtually no delays.

In use for more than fifteen years, the effectiveness of telestroke is now being documented in long-term research. A ten-year study of telestroke in rural areas of Germany, published in the September 2014 issue of American Heart Association’s journal Stroke, reported several impressive data points. The number of patients receiving treatment for ischemic (clot-caused) stroke rose from 2.6 percent to 15.5 percent. In addition, elapsed time between patient arrival at a regional hospital treatment decreased from 80 minutes to 40 minutes.4

As the fourth leading cause of death in the U.S. and the leading cause of disability, getting patients to treatments faster can have a broad impact on population health. With the use of mobile devices for image viewing and diagnosis, that treatment is happening faster than ever.

HIPAA Regulations
Health IT departments see a different trend with mobile devices: Increased risk to patient health information (PHI) security. In a July 2013 survey, 69%t of health IT specialists said they view mobile devices as a threat to the security of patient data regulated under the Health Insurance Portability and Accountability Act (HIPAA).5

These demands put a lot of pressure on health IT departments which must ensure patient data security throughout the enterprise. They need tools and services that support mobile access with built-in, compliant security.

Image sharing is a particularly challenging area for HIPAA-compliance and security. A trauma surgeon can send an image of a wound to a plastic surgeon, which is simple enough given the capabilities of a smartphone but unless the connection between the two doctors is secure both are violating HIPAA rules.

Some image-viewing solutions send patient data to the end-user device, allowing easy access to that data if the devices are stolen. In some cases, data is not being left on the device, but is being rendered on the users laptop or mobile device which can lead to data being left in the memory. The only way to ensure 100% security is to never move the data at all.

Joy Pritts, former chief privacy office at the Office of the National Coordinator for Health Information Technology (ONC), the federal entity charged with coordinating nationwide efforts to implement and use advanced health IT, said in a recent interview, “With respect to the vendors in particular, we really believe they need to make a concerted effort to build security into their products and do it in such a way that it’s easy to use. Because if it’s hard to use, the providers won’t utilize it.”6

The Most Secure Mobile Data isn’t Mobile At All
On August 1st, the FDA released new rules that exempts many medical applications created for mobile devices from its regulatory scope. In general, the new rules are targeted at consumer applications and devices that the guidelines say are “sufficiently well understood and do not present risks that require premarket notification review to assure their safety and effectiveness,” such as thermometers and stethoscopes.

This newly revised focus is in part a response to the proliferation of health and fitness applications for consumers that have a very different end-of-life cycle than medical devices that the FDA has seen in the past. “The whole mobile app world has its own ecosystem where things live, die and sort of recycle again.and it’s mostly consumer driven,” said Bakul Patel, senior policy adviser for FDA’s Center for Devices and Radiological Health.7

Clinical Mobile Medical Applications
Clinical applications, however, remain fully within the FDA’s regulatory scope. These applications include devices and software already regulated by the FDA, such as enterprise image-viewers used for diagnosis, or software that turns smartphones into clinical devices, such as an application for detecting abnormal heart rhythms. From the FDA’s perspective, if such an application were to malfunction, it would pose a risk to patients and must go through the same stringent reviews already required for medical equipment and software. According to the FDA, about 100 mobile medical applications have been cleared over the past decade and about 40 of those were cleared in just the past two years. 8

“We want all of our customers to be able to rely solidly on the safety and effectiveness of ResolutionMD,” explains Kyle Peterson, Director, Regulatory & Corporate Affairs at Calgary Scientific. “It is very important for us to devote the time and resources required to meet the FDA’s requirements to be accredited for diagnostic use.”

Pierre Lemire is president and CTO, Calgary Scientific.

References

  1. Ventola CL. Mobile Devices and Apps for Health Care Professionals: Uses and Beneifts. Available at: www.ncbi.nlm.nih.gov/pmc/articles/PMC4029126/#__sec2title.
  2. Ward MM, Ullrich F, Mueller K. Extent of Telehealth Use in Rural and Urban Hospitals. RUPRI Center for Rural Health Policy Analysis. Available at: http://cph.uiowa.edu/rupri/publications/policybriefs/2014/Telehealth%20Utilization.pdf.
  3. Vesely R. Telestroke Hits the Mainstream, but Can Other Specialties Follow Suit. Available at: www.ihealthbeat.org/insight/2014/telestroke-hits-the-mainstream-but-can-other-specialties-follow-suit.
  4. American Heart Association. TeleStroke units improve stroke care in underserved areas. Available at: http://newsroom.heart.org/news/telestroke-units-improve-stroke-care-in-underserved-areas.
  5. Pai A. Survey: Mobile, Cloud Computing Are Source of Most Healthcare Security Worries. Available at: http://mobihealthnews.com/23519/survey-mobile-cloud-computing-are-source-of-most-healthca%20re-security-worries/.
  6. Sutner S. Joy Pritts: Health Data Security Features Must be Useable. Available at: http://searchhealthit.techtarget.com/feature/Joy-Pritts-Health-data-security-features-must-be-us%20able.
  7. Barajas J. FDA Regulation Can’t Keep Pace with Mobile Apps. Available at: www.pbs.org/newshour/rundown/fda-regulation-unable-keep-pace-new-mobile-health-apps/.
  8. U.S. Food and Drug Administration. FDA Issues Final Guidance on Mobile Medical Apps. Available at: www.fda.gov/newsevents/newsroom/pressannouncements/ucm369431.htm.

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