iRegulate: Should Medical Apps Face Government Oversight?

With medical applications for smart phones becoming a more prominent part of doctors' diagnostic tool kits, the FDA is considering how it should regulate the market--if at all















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For the FDA the challenge will be to keep patients safe without impeding innovation. As Wilcox explains, whereas with prior new technology only tech-savvy young medical residents were willing to give it a whirl, today the interest is nearly ubiquitous among those in the profession. "Now you can build work flows around it rather than just letting people figure out how it helps them," Wilcox says. Apps such as PracticeRx, a safety notification system, could bring vital improvements to medical care by reporting medical errors to a central database. Programs that alert doctors to their patients' potential emergency room visits could save enormous amounts of health care dollars: ER inpatient stays are among the most expensive components of health care, and simply being able to reach a physician through an app could prevent an unnecessary admittance. The technology is also in sync with the electronic health records movement, likely adding momentum to mobile technology adoption.

Wilcox acknowledges a potential need for regulation of apps that go beyond communication and reference, such as those that monitor a patient's pulse or interpret electrocardiogram rhythms. But "the [apps] that should be regulated...are just a tiny fraction of what the real use is," he says. "It would be unfortunate if people interpreted regulation of the smart phone as a reason not to use it."



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  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.
    =============
    <a href="http://leadingmedication.com" rel="dofollow">Leading Medication</a>

    Reply | Report Abuse | Link to this
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