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mHealth Shouldn’t Wait for Government Guidelines That Won’t Be Clarified For Years

Secretary of Health & Human Services Kathleen Sebelius

Recently, Bradley Merril Thompson, a representative of the mHealth Regulatory Coalition (MRC), wrote a letter to Health and Human Services Secretary Kathleen Sebelius, asking the FDA to issue final guidance over mobile health application regulation, “as soon as reasonably possible.”

While it’s tempting to make a snarky remark about the government’s versus the private sector’s definition of “as soon as reasonably possible,” I’ll refrain and state simply that the FDA’s glacial response on this one may have led to slowing of development and investment in mobile health.

Interestingly, Mr. Thompson adds, “Some people mistakenly believe that the final guidance will expand FDA jurisdiction. It will not.”

I’m not so certain. I think the level of direct FDA involvement and regulation will come about largely in reaction to how the industry at large interprets and acts upon the guidelines. That’s as it should be. Let the marketplace determine the viability of mobile health products, with a prudent approach that acknowledges the FDA’s responsibility to safeguard public health. I fully expect that, after the guidelines are released, there will be a formative period where entrepreneurs and the government will work – as partners and sometimes as adversaries – to better define what’s best for the market and for consumers.

I believe that’s the attitude that should be guiding the industry today, while it waits (and waits) for FDA guidance. No business venture is without risk, but the companies that are willing to advance now, confident that their products are safe and effective, are much more likely to prosper and establish market presence than those who continue to wait.

 

Posted in: Digital Health, Health 2.0, Healthcare Marketing, Home Healthcare, Marketing Medical Devices, Medical Device Marketing, Medical Devices, mHealth, Uncategorized

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In-Home Medical Devices, Tracking Wellness Trends

This week I attended a webinar hosted by IBM on the trends for in-home medical devices based on research done in 2010 with over 1,300 US and UK consumers by IBM’s Institute for Business Value. (Here’s the link to the webinar http://bit.ly/bSgY73 )

What I found most interesting was that the research toppled some well-established assumptions such as: 1) consumers are unhappy with their current in-home wellness devices; and 2) in-home devices are mainly used for known health conditions (vs. preventative care devices).  On both counts the research results came back opposite of the ‘common assumptions’.  It seems that consumers are satisfied with their current devices and are ready for more, especially as people become so attuned to using small hand-held electronic devices.  And it seems that the message about preventative care and the benefits it affords is making its way into the home. That to me equates to market opportunities for ‘prevention devices’ (like tracking exercise and physical activity) and even remote monitoring of “someone’s changing health conditions”.

Posted in: Healthcare Marketing, Home Healthcare, Medical Devices, Patients as Healthcare Consumers, Wellness

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