On September 4, 2013, the FDASIA mandated workgroup presented their recommendations to the Health IT Policy Committee in Washington, D.C. Some reporting on the meeting cast the draft report as downplaying potential FDA regulation of healthcare IT applications (HIT), while others emphasized the uncertainty (subscription required) of the process and ultimate outcome. Such news stories are, by necessity, short and can’t cover all the issues but this one from iHealthBeat provides a good summary.
The final report (links to all draft documents) was submitted September 4, 2013 and was basically unchanged from the preliminary report.
The question to be answered by the workgroup was how to regulate HIT. I think we’re past the question of whether or not HIT should be regulated: there have been reports of patient deaths starting in 2005 (here and here), and that’s with almost zero reporting requirements on the part of providers or vendors, and the proliferation of HIT vendor non-disclosure and hold harmless agreements to supress reporting (see reports here and here).
The report, also called the “Section 618 report” for the section of FDASIA that mandates the workgroup and their report, is extremely concise and to the point – perhaps too concise for those outside the world of regulated medical devices. Of the three entities, FDA, ONC and FCC that are the focus of the report, by far the most focus was on the FDA. ONC and FCC received minor recommendations. This blog post focuses on the FDA issues and recommendations. You will have to read the workgroup’s recommendations yourself to pick up the specifics regarding ONC and FCC.Read More
A while back I was provided with a review copy of the book, Electronic Health Record: A Systems Analysis of the Medication Domain, by Alexander Scarlat, MD. This book is intended to serve as a practical book about electronic health/medical records systems as used in acute care settings. (For the purposes of this review, the term EHR is intended to refer to both EHRs and EMRs.)
There are two audiences for the book. The first group includes clinicians with little or no expertise in information technology. There are plenty of books for clinicians that provide an introduction into the common capabilities of an EHR. Scarlat’s book goes a step further, providing the understanding and tools to be able to collaborate with the IT folks who are implementing an EHR so that clinicians can actively participate and communicate their needs and preferences in an unambiguous way. The second audience includes IT professionals who lack in depth knowledge and understanding of clinical workflows that are automated in the typical EHR. For them, the book details what is perhaps the most complex and challenging EHR application, medication ordering.Read More
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