Final MDDS Rule Signals FDA Shift to Enforcement

Final MDDS Rule Signals FDA Shift to Enforcement

On February 14, 2011 the FDA published notice (PDF version [link fixed] and press release) of the long awaited final rule for medical device data systems (MDDS). The real news behind the final MDDS rule is not the less-burdensome path to market trumpeted by many news stories, but the FDA’s stated intent to exercise “enforcement discretion” with regard to those who create MDDS. For the MDDS vendors who are already regulated (Capsule Tech, Cardiopulmonary Corp, Dawning TechnologiesNuvon and others) this final rule is an easing of the regulatory burden. For those that aren’t (e.g., Bridge-Tech Medical, CareTrends, iSirona and others – I currently track 16 companies in the MDDS category) this final rule signals that FDA enforcement actions will be forthcoming for manufacturers that don’t meet FDA’s implementation deadlines (more on that later).

The final rule reclassifies MDDS from a Class III postamendment device to Class I (general controls). Device reclassification has been used before to signal industry that FDA is transitioning from “regulatory discretion,” where the FDA takes a wait-and-see approach to nascent markets, to pursuing “enforcement discretion” to actively regulate new market segments.

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Meaningful Use Stage II

Meaningful Use Stage II

My February, 2010 discussion of Meaningful Use (MU)  (found here) addressed the then proposed 25 elements by which an EMR/EHR (hereafter EMR) would be judged in order to determine if it met the funding standard for MU under the U.S. federal incentive program regulations. Note that in this regard an EMR must be capable of MU, and then MU must be actually achieved by the end user. Capability is established by vendor certification.

As is perhaps common in the sequence of proposed and revised federal regulations, that the scope of the 25 elements received a degree of adverse response that centered on the assertion that they were overly demanding, i.e. we want the money, we just don’t want to work that hard to get it. As a result the 25 required elements were reduced to two sets of requirements in what is now called Stage 1. The first set is 15 required elements while the second is a “menu” of  10 additional elements of which 5 must be chosen.

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Announcing the 2011 Medical Device Connectivity Conference

Announcing the 2011 Medical Device Connectivity Conference

This year’s connectivity conference is scheduled for September 8-9 at the Joseph B. Martin Conference Center at Harvard Medical School in Boston. This is the same location as the inaugural conference in 2009, and was a great venue for both general sessions and break-out tracks. Exhibitor’s booths line the wide walk ways that lead to the conference rooms, rather than a separate lobby (or tent as we had in San Diego in 2010).

I’m already working to line up speakers – if you’ve got a topic to suggest, or want to present yourself, let me know.

The focus of this year’s conference may extend a bit beyond the acute care (hospital) market into ambulatory settings (patient’s homes and use in daily life). Now there are already several conferences on connectivity in ambulatory markets (Healthcare Unbound, mHealth Summit, Connected Health Symposium), but they focus little on specific connectivity issues.

Conference topics typically come from recent and current issues that crop up  in my consulting practice, and buzz in the industry (which is where you come in). Here are some of the topics that are being considered for this year’s conference:

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