Author Archive

The mHealth Regulatory Coalition released a set of suggestions for the FDA’s medical app guidance on Friday, September 30, 2011. In these comments, the MRC outlined changes that need to be made to mobile app risk assessment, marketing definitions for mobile devices, and classification of mobile device add-ons.

As a means of assessing the amount of risk a mobile app may cause a user, the MRC has created a risk assessment tool in the form of a color-coded matrix that they hope the FDA will find useful. The group claims that the tool can determine the “true risk” of a mobile medical app by comparing how likely it is for the device to fail against the amount of danger posed if the app does fail. The MRC sees this as the most useful means of classifying the application because, although app features are hard to regulate because they change frequently, this tool will capture the functionality of the device.

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As a larger percentage of the population grows older and healthcare budgets shrink, the healthcare industry must look for innovative ways to reduce costs without decreasing the quality of care provided. Luckily, mobile healthcare (mHealth) provides a means for connecting patients and healthcare providers directly and efficiently. mHealth is not limited to disease treatment, but also includes strategies for health maintenance in both well and at-risk patients, reducing healthcare costs by decreasing the need for doctor and hospital visits. Therefore, a good mobile strategy is necessary for any healthcare business that is looking for a way to save money while connecting personally with its consumer base.

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Growing an agency business is a unique undertaking because it involves increasing revenue for your clients as well as yourself.  The most important step you can take in order to link the two is to build a marketing infrastructure that supports a wide variety of marketing channels and has the capability to leverage the added benefits of cross channel strategies.  Doing so will allow your agency to bring new clients on board no matter what their requirements are, as well as generate better results than your competition by leveraging all the channels available to you.

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Innovation in technology has dramatically changed the hospitality industry in terms of providing people with access to great service and resources. However, while new technology has found a large audience in the customer service realm, it is often neglected when it comes to marketing. Send out the right message—that your hospitality business is forward thinking and innovative—by marketing in a way that catches the attention of prospective customers and shows off the great services you offer.

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As mobile devices enter the healthcare realm, security concerns can often decrease their potential for speed and productivity. This issue of security versus productivity is addressed in the debate between hospital utilization of virtual or native applications for viewing EHRs via iPads.

While both sides have their benefits and costs, Tom Richardson, the CIO of Deaconess Health System and a proponent of physician ownership of iPads, argues for utilization of a virtualized environment for EHR access.

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Established countries like the US have a lot to learn from emerging countries about the implementation of mHealth.

In fact, the World Congress 3rd Annual Leadership Summit on mHealth emphasized the importance of mHealth-driven preventative strategies for both emerging and established nations. This is in response to hospitals worldwide  spending most of their money and focusing most of their time on reactive care rather than working toward preventing health issues.

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As hospitals begin to move toward mHealth technologies in an effort to revamp health care, the question of whether physicians should use their own mobile devices or hospitals should purchase them for their staffs becomes more pressing.

Todd Richardson, CIO with Deaconess Health System, Evansville, Ind., spoke from personal experience at the World Congress Leadership Summit on mHealth in Boston last week, where he argued for the importance of allowing physicians to use their own devices at work.

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On Tuesday, July 26, 2011, Manhattan Research released a study that demonstrates a strong desire from ePharma Physicians for access to prescription drug information and online promotion programs from their mobile devices.

Defined by the research group as those physicians who already utilize digital communication channels for corresponding with pharma reps and resources, ePharma Physicians make up 87 percent of the US physician population. The study reveals that 45 percent of this population, or approximately 40 percent of all US physicians, desire access to this information via their smartphones or iPads.

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On Tuesday, July 19, 2011, the US Food and Drug Administration released a draft of guidelines designed to begin the gradual introduction of regulations within the ever growing mobile medical application domain. Although this draft was nowhere near to all-inclusive, it was designed to address what the FDA views as the pressing issues presented by these apps, allowing room for later additions if changes or challenges within mHealth present the need.

In order to identify specifically which applications these regulations would apply to, the FDA laid down a narrow definition of a mobile medical app in its draft. This definition rests within the context of mobile platforms, which are devices that are sold specifically as handheld computing platforms, and mobile apps, which are software or online software applications that are designed to run on a mobile platform.

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The FDA’s classification and approval of mobile devices is currently shrouded in uncertainty. In efforts to remedy this confusion for developers and FDA officials alike, the developers involved in the mHealth Regulatory Coalition have created a proposed means of categorization, putting forth suggestions regarding how mobile applications should be regulated and approved.

In its FDA Regulation of mHealth Proposed Draft Guidance Outline the coalition developed a set of suggestions that it intends to submit to the U.S. Food and Drug Administration to consider while laying down official guidelines in late summer or fall of this year. Included in the coalition’s submission will be a written explanation outlining the factors that were incorporated in its risk analyses and category assignments for mHealth devices.

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