The Office of the Inspector General (OIG) of the U.S Department of Health and Human Services has released a report (pdf) outlining its 2015 work plan. Among a host of subjects is “Information Technology Security, Protected Health Information, and Data Accuracy” with the subsection “Controls over networked medical devices at hospitals”. The focus here is on the security of patient electronic health information which is to be protected under law. Other risks associated with device networking are not addressed.Read More
The recent recall (links below) for McKesson’s Anesthesia Care system raises interesting questions about potential information system failure modes as well as what system/software functions cross the imaginary line between unregulated EHRs and regulated medical devices.
First the facts. The FDA announced McKesson’s voluntary recall of its Anesthesia Care system in several on-line (here, here and here) postings. This trio of postings is interesting because the first links only to the second, the second does not link to either of the other two. The third also does not link to the other two, and was not part of any of the announcements, but it is the most complete.
The statement of the reason for the recall is that, “There was an occurrence where the patient case data did not match the patient data when the case was recalled in the anesthesia care record (ACR) in that it included data from another case.” It was further noted that, “Use of this affected product may cause serious adverse health consequences, including death.” In the third link the FDA identifies the product as,Read More
Introduced in the House back in October was the wittily named Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013 which has the acronym SOFTWARE. Not to be outdone on the creation of legislative acronyms, now comes the Senate version with a bill entitled Preventing Regulatory Overreach To Enhance Care Technology, which of course gives us PROTECT. Both of these bills seek to define and sub-define medically related software, and then to take part of what they have defined away from the FDA, and do something else with it that has not yet been clearly identified.
The premise of these bills is that the FDA inhibits entrepreneurs by peskily requiring, at least in some cases, that the developer meet regulations that are supposed to provide some measure of safety and efficacy before these products are used for or by the public. These issues arise in part because the definition of a medical device does not explicitly include or exclude software. This has allowed the occasional debate about whether and what kind of software is or is not a medical device. The FDA’s position is to simply look at the function of the software and the definition, and then to say that if what the software does meets the definition then it is a medical device. Debating this with the FDA is typically not a fruitful endeavor. Some other countries have explicitly included software, presumably to try to end the discussion. For example the UK explicitly includes “software” in its list of the multiple categories of things that may be a medical device.Read More
Some time ago Tim Gee pointed out that a major vendor for an in hospital communication system included the following statement in its documentation:
“This product is not intended for use with patient monitoring devices or other patient care devices. Do not use this product as the primary communications tool in health care environments, as it may use an unregulated frequency band that is susceptible to interference from other devices or equipment.”
Of course “primary communication” was exactly why the product was being purchased, and arguably what it was being sold for.
When discussing Clinical Decision Support (CDS) (here) I have pointed that it is common for CDS creators to in essence say that one should not rely on the output of the product, but instead always second guess the advice provided. This perhaps approaches a warning that I proposed for a product that I thought was seriously defective: DO NOT USE THIS PRODUCT. Maybe I was being facetious.
These examples may pale in comparison to the following disclaimer for medical image processing software:Read More
On July 21, 2011 the FDA released its “Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Application.” We have discussed this draft and mobile apps generally here, here, and here. As with all draft guidance documents, following the release of the draft the FDA is supposed to receive and review comments (reported to be about 130), and then issue a revised draft, a final guidance document, withdraw the draft, or do none of these for an extended period, just letting the draft sit. The latter appears to be the fate of many drafts. The two years that this draft has been out probably qualifies as an extended period. However the FDA did tell Congress, and the public, that the guidance would be released by the end of this fiscal year. Outsiders cannot tell if the appropriate FDA people are hard at work on this item, or if they are distracted in part by other issues. The FDA’s claimed devotion to transparency does not include being able to see how such things are progressing.Read More