As noted before, from time to time I answer questions and exchange ideas with folks from hospitals, companies and with students. It’s a karma thing with me – if I can help out with reasonable effort in situations where there’s no immediate consulting opportunity (although there may in the future), and it’s interesting, then I do what I can.
The following is the most recent exchange from a conversation I’ve been having with a product manager at a HIT software vendor about MDDS. They develop and sell an information system, part of which consumes medical device data. Not every customer already has an MDDS, and those that don’t look to their company to provide one as part of a “complete solution.”
From my research, it seems that having FDA clearance for MDDS seems to assure that the product will work out of the box and it’s tested for safety and effectiveness and seems to be a better choice to have than an MDDS (reliability, safety for patients).Read More
Last month I spoke at the first CIS Qatar International Conference in Doha Qatar. My topic was the Importance of Enterprise Wide Medical Device Integration in CIS workflow. You can download a copy of my presentation here.
This was the first such conference in Qatar with over 1,500 people attending. The ballroom only had capacity for 1,200 so they had remote screens and audio for the 300 overflow attendees. Several hospitals in Qatar are in the process of implementing Cerner’s EMR, so there is a lot of keen interest in all things EMR.Read More
In preparing for my presentation on Stage 2 Meaningful Use (MU) requirements for the November, 2012 Fourth Annual Medical Connectivity Conference I had the opportunity to delve further into the question of what had to be connected to what, and interoperable with what, in order for providers seeking EHR incentive payments to satisfy their MU obligations. (I ended up making this presentation by phone from New York to Boston because of the lack of transportation out of New York post hurricane Sandy.)
Stage 2 of the federally defined Meaningful Use (MU) is now upon us (details here), and a recurring theme is clearly interoperability. But what this means, and to whom, has not always been clearly presented. In this regard there has been occasional talk from the medical device engineering side of the room that MU requires that a variety of “traditional” medical devices must be able to send data to the EHR.Read More
Since my last blog post here at Medical Connectivity there have been some mHealth updates that may be of interest to the blog readers.
USA and FCC
Just this week the FCC released its task force findings on mHealth. The overarching goal given to the task force was: “By 2017 mHealth, wireless health and e-Care solutions will be routinely available as part of best practices for medical care.” They were to produce actionable recommendations that could be taken by the FCC, other regulatory agencies and industry to reach this goal. The FCC committed to implementing five specific actions in the list produced by the task force:
a) Immediately recruit for an FCC Medical Director position
b) Develop and execute a health care stakeholder outreach plan to promote greater collaboration between the FCC and the health care sector on policies at the intersection of communications and health.
c) Direct the International Bureau to work with FCC counterparts in other countries to encourage them to make spectrum available for MBANs and to discuss possible spectrum harmonization to allow for medically safe cross-border patient travel and better economies of scale for device makers.
d) Consider an Order by the end of this year to comprehensively reform and modernize the Rural Health Care Program, and
e) Consider an Order by the end of this year to streamline our experimental licensing rules to promote and encourage the creation of wireless health “test beds” to permit easier testing of mHealth devices.
Today, July 11, 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act. Applauded by big pharma, the American Medical Association, the National Organization for Rare Disorders, and others, this new legislation reauthorizes various user fees, and revises regulations in an effort to address problems around drug shortages, the paucity of therapies for rare diseases, and improving availability of pediatric drugs and devices. For regulatory geeks, there is also new language around the “least burdensome standard,” modification of de novo application process, reclassification procedures and more. You can see a bill summary of the legislation here, and download the actual law here (pdf).
Unique Device Identifier
Two things in the FDASIA (pronounced “F-D-A sigh”) jumped out at me: unique device identifier and health information technology. Section 614 directs the Secretary of HHS to issue proposed unique device identifier (UDI) regulations by December 31, 2012, and to finalize the proposed regulations not later than 6 months after the close of the comment period.
In general, the UDI is a good thing in that it will likely contribute to improved supply chain efficiency. All the claims about improved post market surveillance, patient safety and quicker, more reliable recalls are considerably beyond the ability of what is really just a hopped up serial numbering scheme. To achieve the widely trumpeted safety benefits would require the wide adoption of an information system that does not yet exist. There are a lot of cool ways such an information system could come into being – the feds, some outfit like the ECRI Institute, or an open source software project driven by hospitals. And of course, you’d have to get health care providers to, you know, actually use the software.
Needless to say, the easy part with be getting the UDI onto products (and that’s taken years).
The big news for many folks is that there is now a legislative mandate to regulate HIT.Read More
I have previously discussed Meaningful Use (MU) criteria for EHRs (here and here) , and Clinical Decision Support (CDS) (here). These topics are closely linked since the MU requirements mandate the inclusion of CDS.
On February 22, 2012 the Centers for Medicare and Medicaid Services (CMS) released (in a mere 455 pages in manuscript form) a proposed rule for Stage 2 criteria for qualification of an EHR for the Medicare incentive program. Among many topics, the proposed rule includes some elaboration on the mandatory use of CDS’s as well as issues related to their design and utilization.Read More