Valuing Private Certification
There are currently several private entities that seek to certify medical apps, connectivity solutions, EHR record exchange, and other products, services and people in our sphere of interest. Given the ongoing proliferation of private certifications, there is a growing need to evaluate them, judge their relative costs and benefits, and determine which – if any – are worth adopting as either the one certified or as the consumer of certified products or services.
These private activities are usually distinct from governmental requirements (e.g. FDA or FTC compliance, or state licensing), although in the case of EHR Meaningful Use (MU) certification, private entities function on behalf of the federal government to certify compliant EHRs. Note here that compliant EHRs are those that are capable of achieving MU. Purchasing a product that is thus certified is a prerequisite for a provider then achieving MU.
How Big a Loophole is “Wellness”?
The medical app and regulatory pot is being stirred as products continue to appear, including those with questionable FDA credentials, or lack of credentials.
As discussed in our earlier posts on apps regulation (here and here), an app is a medical device if its meets the congressionally mandated and FDA enforced definition of a medical device as something whose intended use “is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man”. As stated in the FDA’s Draft Guidance, omitted from this definition, and therefore not medical devices, are apps “that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness.”
EHR MU – Interoperability, but of what?
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.
The FTC Weighs in With Mobile App Advice
Those of us engaged in medical devices and their connectivity often (or perhaps not often enough) look to the FDA for regulation and guidance. In these pages there has been discussion of FDA regulation generally (here), as applied to Medical Device Data Systems (MDDS) (here), medical device mobile apps (here and here), and clinical decision support systems (here)
We sometimes remember that there are also other government agencies that may have impact on what we do. For examples the role of the FCC has been discussed here with respect to medical device wireless applications, and more recently the prospect of the FCC taking away part of the Wireless Medical Telemetry Spectrum (WMTS) has received attention in clinical engineering circles (while no one else seems to care). CMS is always of interest with respect to medical device reimbursement, and more recently with respect to meaningful use of electronic health records (EHR), which may or may not be medical devices. Advertising of medical devices is regulated by both the FDA and the FTC, and some over-the-counter devices bridge the FDA and Consumer Products Safety Commission divide. The FTC (but curiously not the FDA) has previously gone after smart phone acne treatment apps because of their “baseless claims.” When there is dual authority and a need for regulatory action I have wondered if having two responsible agencies is worse than having just one (leading to some new math such as 1+1 < 2, and might even be <1).
More on Clinical Decison Support and EMRs
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.
