The Food and Drug Administration has spent decades refining its processes for approving drugs and devices (and is still refining them), so what would happen if they extended their scope to the exploding health software industry?
The FDA, and its parent organization, the Department of Health and Human Services, are facing an unpleasant and politically difficult choice.
Sticking regulatory fences into the fertile plains of software development and low-cost devices will arouse its untamed denizens, who are already lobbying Congress to warn the FDA about overreaching. But to abandon the field is to leave patients and regular consumers unprotected. This is the context in which the Food and Drug Administration, the Office of National Coordinator, after consultation with outside stakeholders, released a recent report on Health IT.
I myself was encouraged by the report. It brings together a number of initiatives that have received little attention and, just by publicizing the issues, places us one step closer to a quality program. Particular aspects that pleased me are:
- The suggestion that quality programs should start to look at electronic health records (p. 8). EHRs have been certified by various bodies, but usually just to check off boxes and declare that the systems comply with regulations–neither the quality of their user interfaces nor the quality of their implementations have been questioned. Reportedly, the FDA considered “safety and quality standards” for electronic health records in 2010 but couldn’t get them adopted. It also checks certain forms of clinical decision support, but only if they are built into a regulated device. The current HHS report refers back to aspirational documents such as a Health Information Technology Patient Safety Action & Surveillance Plan and a set of guidelines on the safety of EHRs.
- A call for transparent reporting and sharing of errors, including the removal of “disincentives to transparent reporting”–i.e., legal threats by vendors (p. 25). Error reporting is clearly a part of the “environment of learning and continual improvement” I mentioned earlier. A regulation subgroup stated the need most starkly: “It is essential to improve adverse events reporting, and to enable timely and broader public access to safety and performance data.” Vague talk of a Health IT Safety Center (p. 4, pp. 14-15) unfortunately seems to stop with education, lacking enforcement. I distinctly disagree with the assessment of two commentators who compared the Health IT Safety Center to the National Transportation Safety Board and assigned it some potential power. However, I will ask ONC and FDA for clarification.
- A recognition that software is part of a larger workflow and social system, that designing it to meet people’s needs is important, and that all stakeholders should have both a say in software development and a responsibility to use it properly.
Don’t imagine that the FDA is unused to regulating software. For quite some time they have instituted practices for the software used in some medical devices , and have tried to keep them up-to-date.
A waterfall-like process of risk assessment and testing called computer system validation has long been required for pharma and devices.
Continue reading “Health IT: The Coming Regulation”
Filed Under: Tech, THCB
Tagged: Andy Oram, Device software, EHR vendors, FDA, FDA regulations, HHS, HIT, Medical Devices, Patient Safety, software errors
Apr 14, 2014
Three related columns in HealthcareITNews caught my attention recently.
The headlines pretty much say it all:
1. Satisfaction with HIE solutions drops.
2. Vendors missing boat on HIE needs.
3. CommonWell names 3 biggest HIE hurdles.
Over the years, I’ve written more than a few HealthBlog posts on the topic of health information exchange (HIE) and why I feel so strongly that most of the initiatives currently underway are missing their mark.
As I’ve stated before, during my worldwide travels I haven’t yet come across a country that has accomplished a truly national, interoperable, bi-directional, fully functional HIE.
Those few countries that come close are more like a large American city or small state in size, perhaps mirroring some of the moderately successful regional or state-wide exchanges currently operating in America. Over the years I’ve also watched implosions of national HIE attempts in several countries that have failed miserably despite billions of dollars being spent on the efforts.
Reading each of the articles referenced above, I once again reach the conclusion that what I have been evangelizing as a better model for HIEs still rings true.
Continue reading “Cracking the Code on Health Information Exchange. Is It Time to Wipe the Slate Clean and Start Anew?”
Filed Under: Tech
Tagged: Bill Crounse, EHR vendors, EHRs, health information exchange, HealthVault, HIT, Tech
Apr 6, 2014
At HIMSS 2014, the health information technology’s (HIT) largest annual confab, the bestest-best news we heard from a policy perspective, and maybe even an industry perspective, was the Centers for Medicare & Medicaid Services’ (CMS) dual announcement that there will be no further delays for either Meaningful Use Stage 2 (MU-2) or ICD-10.
Perhaps we should have immediately directed our gaze skyward in search of the second shoe preparing to drop.
As it turns out, CMS de facto back-doored an MU-2 delay by issuing broad “hardship” exemptions from scheduled MU-2 penalties. To wit: any provider whose health IT vendor is unprepared to meet MU-2 deadlines, established lo these many months ago, is eligible for a “hardship” exemption.
Few would disagree with the notion that it’s unproductive to criticize policy without offering constructive ideas to fix the underlying problems.
Here, the underlying problem is easy to define: it is in point of irrefutable fact fundamentally unfair to penalize care providers for their vendors’ failings—especially when the very government proposing to penalize them put its seal of approval on the vendors’ foreheads to begin with.
CMS’s move to exempt providers from those penalties is correctly motivated, but it seeks to ease the provider pain without addressing its cause.
Instead of issuing a blanket exemption for use of unprepared vendors, CMS should:
- Waive penalties only for those providers who take steps to replace their inferior technologies with systems that can meet the demands of the 21st century’s information economy;
- Publish lists of health IT vendors whose systems are the basis for a hardship exemption, along with an accounting of how many of those 21 billion dollars have been paid to subsidize those vendors’ products; and
- Immediately initiate a reevaluation of the MU certification of any vendor whose products form the basis for a hardship exemption.
This proposal might seem bold, but if we’re truly looking to advance health care through the application and use of EHR, then what I’ve outlined above simply represents necessary and sound public policy. Current practice rewards vendors whose products are falling short by perpetuating subsidies for those products.
The federal government should stop paying doctors to implement health IT that cannot meet the standards of the program under which the payments are issued. That’s just a no-brainer.
An EHR should not be a federally-subsidized “hardship.”
Continue reading “Congratulations, Doctor, On Your Federally-Subsidized “Hardship””
Filed Under: Tech, THCB
Tagged: CMS, Dan Haley, EHR, EHR vendors, Hardship Exemption, HIMSS 2014, HIT, Meaningful Use Stage 2, Providers
Mar 13, 2014
The Massachusetts Medical Society may be the first to notice that Meaningful Use EHR mandates favor large providers and technology vendors. Control over the Nationwide Health Information Network sets the stage for how physicians refer, receive decision support, report quality, and interact with patients. State health information exchanges and policy makers are caught in the cross-fire over health records interoperability. Are the federal regulations over Stage 2 being manipulated to put physicians and the public at a disadvantage?
On Dec. 7, the Massachusetts Medical Society took what might be the first formal action in the nation. A resolution stating:
“That the Massachusetts Medical Society advocate for a more open, affordable process to meet technology mandates imposed by regulations and mandates; e.g., that all Direct secure email systems, mandated by Meaningful Use stage 2, including health information exchanges and electronic health record systems, allow a licensed physician to designate any specified Direct recipient or sender without interference from any institution, electronic health record vendor, or intermediary transport agent.”
Scott Mace’s column Direct Protocol May Favor Large Providers and Vendors is the first to report on this unusual move by a professional society. Full disclosure: I’m a member of the MMS and the initiator of what became this resolution.
Meaningful Use is intended to support health reform by promoting interoperability and innovation in health service delivery. The Affordable Care Act, Obamacare, is fundamentally a free-enterprise model without single payer or even a public option. Obamacare depends on the market for eventual cost controls and sustainability. Meaningful Use is regulation designed to enable market-driven health reform by reducing interoperability barriers.
Although Meaningful Use regulations have already handed out $17 Billion to drive “voluntary” adoption of interoperable electronic health records, meaningful interoperability is still elusive. Meanwhile, the doctors are chafing about Meaningful Use intrusions and policymakers worry that the regulations will actually increase costs.
Continue reading “It’s Doctors versus Hospitals Over Meaningful Use”
Filed Under: Tech, THCB
Tagged: Adrian Gropper, EHR, EHR vendors, Hospitals, Massachusetts Medical Society, Meaningful Use Stage 2, Physicians
Dec 12, 2013
A common and somewhat unique aspect to EHR vendor contracts is that the EHR vendor lays claim to the data entered into their system. Rob and I, who co-authored this post, have worked in many industries as analysts. Nowhere, in our collective experience, have we seen such a thing. Manufacturers, retailers, financial institutions, etc. would never think of relinquishing their data to their enterprise software vendor of choice.
It confounds us as to why healthcare organizations let their vendors of choice get away with this and frankly, in this day of increasing concerns about patient privacy, why is this practice allowed in the first place?
The Office of the National Coordinator for Health Information Technology (ONC) released a report this summer defining EHR contract terms and lending some advice on what should and should not be in your EHR vendor’s contract.
The ONC recommendations are good but incomplete and come from a legal perspective.
As we approach the 3-5 year anniversary of the beginning of the upsurge in EHR purchasing via the HITECH Act, cracks are beginning to show. Roughly a third of healthcare organizations are now looking to replace their EHR. To assist HCO clients we wrote an article published in our recent October Monthly Update for CAS clients expanding on some of the points made by the ONC, and adding a few more critical considerations for HCOs trying to lower EHR costs and reduce risk.
The one item in many EHR contracts that is most troubling is the notion the patient data HCOs enter into their EHR is becomes the property in whole, or in-part, of the EHR vendor.
It’s Your Data. Act Like it.
Prior to the internet-age the concept that any data input into software either on the desktop, on-premise or in the cloud (AKA hosted or time sharing) was not owned entirely by the users was unheard of. But with the emergence of search engines and social media, the rights to data have slowly eroded away from the user in favor of the software/service provider.
Facebook is notorious for making subtle changes to its data privacy agreements that raise the ire of privacy rights advocates.
Continue reading “Whose Data Is It Anyway?”
Filed Under: Tech, THCB
Tagged: business of healthcare, Chilmark Research, Data, EHR, EHR vendors, John Moore, Privacy, Robert Tholomeier
Nov 20, 2013
Arguably, the biggest news story coming out of HIMSS last month was the announcement of the CommonWell Health Alliance – a vendor-led initiative to enable query-based, clinical data sharing. So much has been written about CommonWell that there is little need to rehash what has been said before.
What has not been said, or at least has been sensationalized nearly to the point of irrelevance is the whole controversy surrounding Epic and how they were not invited to join the CommonWell Alliance until after the announcement. None other than Epic’s own founder and CEO, Judy Faulkner, has gone on record stating the Epic was unaware of CommonWell prior to the announcement. Faulkner has gone on to question the motives of CommonWell, in an effort to subvert it, in her highly influential role on the Dept of Health & Human Services HIT workgroup committee.
That was the last straw.
It is one thing to moan and groan at the HIT love fest that is HIMSS, where vendors commonly discount the announcements of competitors. But it is quite another thing to be a part of a highly influential body that is defining nationwide HIT policy and make the same claims over again, especially when they are frankly not true.
Continue reading “The Story Behind the CommonWell Story”
Filed Under: Tech, The Business of Health Care
Tagged: CommonWell Health Alliance, EHR, EHR vendors, Epic, HIMSS 2011, HIMSS 2013, HIT, Interoperability, Judy Faulkner, Transparency, Wang Laboratories
Apr 13, 2013
The EHR vendor lock-in business model is under attack by frustrated physicians and patients and the reality that health care cost and quality are more opaque than ever. Doug Fridsma of ONC politely talks of the need to move from vertical integration of health care services to horizontal integration where patients can choose with their feet. Farzad Mostashari calls for moral behavior and price transparency. The Society for Participatory Medicine says “Gimme My DAM Data” and Patient Privacy Rights asks HHS to allow physicians to prescribe health IT without interference from the institution or the vendor.
The vendors’ response is a charm offensive called CommonWell Health Alliance with a pastel .org website. The website is presumably the official source of information about CommonWell and it lays out the members’ strategy to preserve the vendor lock-in business model for a few $Billion more. Ok, maybe more than a few.
The core of the CommonWell strategy is to avoid giving patients their data in a timely and convenient way.
Continue reading “The #CommonWell Open Discussion Forum”
Filed Under: OP-ED, Tech, THCB
Tagged: Adrian Gropper, BlueButton, CommonWell, CommonWell Health Alliance, Direct Project, Doug Fridsma, EHR, EHR vendors, Farzad Mostashari, HHS, patient data, Society for Participatory Medicine, Transparency
Mar 18, 2013
The big news at HIMSS13 was the unveiling of CommonWell (Cerner, McKesson, Allscripts, athenahealth, Greenway and RelayHealth) to “get the ball rolling” on data exchange across disparate technologies. The shame is that another program with opaque governance by the largest incumbents in health IT is being passed off as progress. The missed opportunity is to answer the call for patient engagement and the frustrations of physicians with EHRs and reverse the institutional control over the physician-patient relationship. Physicians take an oath to put their patient’s interest above all others while in reality we are manipulated to participate in massive amounts of unwarranted care.
There’s a link between healthcare costs and health IT. The past months have seen frustration with this manipulation by industry hit the public media like never before. Early this year, National Coordinator for Health Information Technology Farzad Mostashari, MD, called for “moral and right” action on the part of some EHR vendors, particularly when it comes to data lock-in and pricing transparency. On February 19, a front page article in the New York Times exposed the tactics of some of the founding members of CommonWell in grabbing much of the $19 Billion of health IT incentives while consolidating the industry and locking out startups and innovators. That same week, Time magazine’s cover story is a special report on health care costs and analyzes how the US wastes $750 Billion a year and what that means to patients. To round things out, the March issue of Health Affairs, published a survey showing that “the average physician would lose $43,743 over five years” as a result of EHR adoption while the financial benefits go to the vendors and the larger institutions.
Continue reading “CommonWell Is a Shame and a Missed Opportunity”
Filed Under: OP-ED, THCB
Tagged: Adrian Gropper, bitter pill, CommonWell, Costs, Data, EHR vendors, HIMSS 2013, HIT, IHE 2.0, Interoperability, Transparency
Mar 6, 2013
It has always been my assumption that my new practice will be as “digital” as possible. No, I am not going into urology, I am talking about computers. [Waiting for the chuckles to subside]
For at least ten years, I’ve used a digital EKG and spirometer that integrated with our medical record system, taking the data and storing it as meaningful numbers, not just pictures of squiggly lines (which is how EKG’s and spirometry reports appear to most folks). Since this has been obvious from the early EMR days, the interfaces between medical devices and EMR systems has been a given. I never considered any other way of doing these studies, and never considered using them without a robust interface.
Imagine my surprise when I was informed that my EMR manufacturer would charge me $750 to allow it’s system to interface with a device from their list of “approved devices.” Now, they do “discount” the second interface to $500, and then take a measly $250 for each additional device I want to integrate, so I guess I shouldn’t complain. Yet I couldn’t walk away from this news without feeling like I had been gouged.
Gouging is the practice of charging extra for someone for something they have no choice but to get. I need a lab interface, and the EMR vendor (not just mine, all of the major EMR vendors do it) charges an interface fee to the lab company, despite the fact that the interface has been done thousands of times and undoubtedly has a very well-worn implementation path. This one doesn’t hurt me personally, as it is the lab company (that faceless corporate entity) that must dole out the cash to a third-party to do business with me.
Doing construction in my office, I constantly worry about being gouged. When the original estimate of the cost of construction is again superseded because of an unforeseen problem with the ductwork, I am at the mercy of the builder. Fortunately, I think I found a construction company with integrity. Perhaps I am too ignorant to know I am being overcharged, but I would rather assume better of my builders (who I’ve grown to like).
Yet thinking about gouging ultimately brings me back to the whole purpose of what I am doing with my new practice, and what drove me away from the health care system everyone is so fond of. If there is anywhere in life where people get gouged or are in constant fear of gouging, it is in health care. Continue reading “Rob’s New Economics of Practice Management”
Filed Under: Physicians, THCB
Tagged: EHR vendors, gouging, Insurance, Pharma, Physician business models, Physicians, practice management, primary care, private practice, Rob Lamberts, Subscription model
Jan 27, 2013
According to CMS, through May of this year, 2,400 hospitals and 110,000 eligible professionals have received $5.7 billion in incentive payments for ensuring meaningful use of electronic health records, representing about half of all eligible hospitals and about 20% of all eligible providers.
Despite this widespread adoption EHRs, reliable market share data by vendor is still very hard to come by. So, when CMS recently updated its attestation data for midyear 2012, we took notice. Attestation, remember, is the process by which practitioners legally verify that they have used an EHR in way that merits one of those incentive payments. The data set includes more than 77,000 different attestations from 2011 through May of 2012 (note that it is not immediately clear why the data set has different totals than the CMS press release).
The sheer number of options for hospitals and providers stood out to us immediately. There are 405 separate EHR vendors that hospitals or providers have used to attest to meaningful use, with 336 of these providing ambulatory EHR products. It’s worth pausing here to note that by our count of the data found on the CMS Certified Health IT Product List, there are more than 550 separate ambulatory vendors with complete EHRs approved by CMS, meaning that despite the huge number of options, there were still well over 200 approved ambulatory vendors that have not had a single user qualify for an incentive payment yet!
Despite this enormous number of options, users attesting were fairly concentrated in the top vendors. Of these 336, the top 15 vendors represented 75% of all providers attesting. On the inpatient side, this concentration was even more pronounced, with the top 6 representing 75% of the total hospital attestations.
When we organize and dig into the data, a few other points stand out.
Continue reading “Numbers Don’t Lie — The EHR Market Must Consolidate”
Filed Under: THCB
Tagged: Allscripts, athenaClinicals, Cerner, EHR vendors, Epic, Health IT, McKesson, Meaningful Use, MEDITECH, Practice Fusion
Aug 6, 2012