When John Allen Reilly visits his hospice patients, he always takes along his iPhone. One of the applications he uses is A2Z of Dermatology to help classify skin conditions and to show photographs to his patients for comparison.

Similar apps for health care professionals include Skyscape's Medical Bag, which contains a host of treatment guidelines such as how to handle various cardiac conditions, read diagnostic lab tests and calculate weight-based dosing as well as On Call Notes, a basic notepad. Along the same lines, medical illustration apps such as 3D Brain Human Body Anatomy work as teaching tools for students (and motivated patients). Other apps have been developed to give doctors access to hospitals' patient charts and other data.

Nearly 1,500 smart phone applications for health care professionals are already available for downloading (along with many more for patients), and by 2012, 81 percent of physicians will have a smart phone, according to a report from Manhattan Research. As apps enter the realm of routine medical care, the U.S. Food and Drug Administration (FDA) must consider whether and how to ensure patient safety around the hodgepodge medical apps market—the top 10 medical apps include Medical Calculator and Sex-Facts. The fact that some specialized medical apps are openly available to anyone with a smart phone may raise additional concerns. But excessive regulation of medical apps could also squelch what might be the part of the next great wave of innovations in health care.

Medical applications are technically medical devices and therefore subject to federal regulation. There currently are no clear federal measures in place, however, to guarantee their quality and accuracy. The FDA is considering various degrees of oversight of so-called health information technology, which includes apps and other digital systems (such as electronic health record software). Regulation could be mild, focusing on postmarket safety via an electronic registry, according to Jeff Shuren, director of the FDA's Center for Devices and Radiological Health. He made his remarks this past February as testimony to the center's committee on health technology.

Manufacturers would be responsible for reporting any problems to the FDA and correcting safety issues, with some higher risk technology subject to closer surveillance. A middle-ground approach would require manufacturers of apps to adhere to specific FDA guidelines on quality and consistency. The most intensive regulation under consideration would require premarket safety and efficacy review of medical apps, as is the case for other clinical devices, such as heart monitors and computed tomography scanners.

An FDA spokesperson declined to comment on whether there are concrete plans to regulate medical smart phone apps and when new policies might be instituted, saying the agency's role in these applications and other health information technology is evolving.

With the rapid integration of apps into routine health care, however, time seems be of the essence. And as many physicians already use apps to check and update patient status, concern about logging crucial data incorrectly is not unfounded. Adverse events resulting from medical apps and other health information technology errors have already been reported to the FDA. Because of a programming error, allergy information for a patient failed to display on a clinical decision support app, according to Shuren's testimony. In another instance, results of a nuclear medicine study were saved in the wrong patient's file when accessed using health care management software.

Although many doctors embrace medical apps, no one is talking about abandoning the use of good clinical judgment or the human touch. Reilly, whose private practice in Frederick, Md., focuses on geriatrics, internal medicine, bariatrics and hospice has 105 apps on his iPhone but emphasizes that they will never replace his own system of checks and balances. "I don't make huge medical judgments [based on apps]," Reilly says. "These are here to help me."

Most currently available apps are simply a way to make it so reference tomes can be accessible on handheld devices, so FDA approval should be unnecessary, says Adam Wilcox, professor of medical informatics at Columbia University. "If the FDA is going to regulate referential information, are they going to monitor the textbooks from which the information is coming from?" he asks.

As another example, Wilcox recently developed an app that allows physicians at New York–Presbyterian Hospital to access patients' online records. The computer-based interface was not subject to regulation, so neither should the app be, Wilcox explains. Kavapoint, which manufactures several top medical apps, distributes medical information from the FDA rather than creating it. "We are confident that the data are correct, because we are taking it directly from the source," says Kavapoint co-founder Joseph Mao, arguing against strong regulations.

7 Comments

1. 1. jtdwyer 12:27 PM 4/12/10

   Reading this article, I am constantly intentionally distracted by the commercial content to the right on these pages. If convenient apps and aids are made available to physicians and other, their development costs will have been financed by commercial interests: the content and results provided will undoubtedly be biased towards those interests, as is all 'freely' available information. goto free-------------.com and see.
   
   If any medical apps are to be at all relied upon by caregivers their results should be biased solely in the interests of patients. If government regulation is required to ensure that, then it should be required.

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2. 2. JHI 04:33 PM 4/12/10

   HIPPA should also be apply to the information on those medical devices

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3. 3. JHI 04:34 PM 4/12/10

   HIPPA should also be applied to information stored in the apps.

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4. 4. GoldFish 04:53 PM 4/12/10

   Medical information is sensitive and it should be protected by some strong authority. Reading this article, it appears that there are lots of medical apps around that are serving the purpose of medical information exchange. There is a strong need to protect the data, data integrity and its usage. When we entered in the cyber space there were no regulatory body around. Both publishers and consumers of data enjoyed the freedom for years, till we invented the term "Cyber Crime". The regulatory body such as FDA and protocol such as HIPPA serve very strong purpose and fill the gaps to a great extent. We must have some well defined process/ mechanism/ protocol for such information exchange and that should happen fast. Let's put a better system and governance around and that will be for the benefits of both app developers/ vendors and its users.

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5. 5. jtdwyer in reply to GoldFish 07:41 PM 4/12/10

   GoldFish - Oh, my! So who has legal custodial care of personal information as it potentially is exchanged among devices in a medical environment? In other words who is responsible if I suffer financially from misuse of my information or medically from erroneous information? What individual or organization is responsible for the accuracy and security of personal information and for decisions made from the presentation of personal information? Is everyone trusted?

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6. 6. domteufel 07:52 PM 4/25/10

   none
   

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7. 7. smithmary 12:32 AM 6/30/10

   It may be a fairly uncommon disease but emphysema is one of the most common reasons for the increasing number of death rates. It is a pulmonary disease which damages your lungs due to the toxic air we breathe. Some of the common chronic obstructive pulmonary diseases are bronchitis, asthma and emphysema. This condition takes place when the lung tissue loses it elasticity and finds it hard to maintain a normal breathing pattern. Many suffer through this disease and have lost their lives in this battle.
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