The Ethics of EHR Vendors

Last week the American Medical Informatics Association (AMIA) released a position paper titled “Challenges in ethics, safety, best practices, and oversight regarding HIT vendors, their customers, and patients: a report of an AMIA special task force”.  The paper shines a bright light on the alleged contracting practices of EHR vendors and their notorious “hold harmless” clauses, which indemnify the EHR vendor from all liability due to software defects, including liability for personal injury and death of patients. What this means in plain English is that if a software “bug” or incompetency caused an adverse event, and if you (or your hospital) are faced with a malpractice suit, the EHR vendor cannot be named a co-defendant in that suit and you cannot turn around and bring suit against the vendor for failure to deliver a properly functioning product. The AMIA paper also asserts the existence of contractual terms preventing users and purchasers from publicly reporting, or even mentioning, software defects, including ones that may endanger patient safety. The AMIA report goes on to challenge the ethics of both buyers and sellers engaging in such contracts, with an emphasis on the EHR vendors’ primary responsibility to shareholders and the bottom line in general.

As expected, the authors call for Government regulation of HIT products and processes and suggest that contracts should, of course, reflect a shared responsibility between vendors and customers and while public reporting should be allowed (or required) for certain types of software defects, users should be mindful of the vendor’s intellectual property. The interesting portion of the report is the rather novel recommendation for formal Ethics education amongst vendors and purchasers. Presumably, vendors and their customers need to be taught the difference between right and wrong and need to be informed that placing corporate profits (or personal comfort) ahead of patient safety is indeed wrong and therefore unethical. To borrow from the Windows 7 phone commercials, “Really?”

If you ever signed a purchase or service contract, you should know that the opening bid from the seller is just that: the opening bid in the negotiating process to follow. EHR contracts are no different. The initial contracts presented by vendors may contain some, all or none of the following:

• Hold harmless or most often limited liability, for personal injury and death resulting from use of the software. The assertion is frequently made that the software is not intended as a diagnosis and treatment tool and is not a substitute for professional judgment. Many times this clause is accompanied by multiple disclaimers of warranties regarding the accuracy and veracity of the clinical content and decision support provided by the software. The purpose of these terms is to insulate the vendor from malpractice suits. It would be very tempting for a plaintiff, who is usually poor and indebted, to include someone like McKesson or GE in the lawsuit. Juries have even less compassion for corporations than they have for “rich” doctors. The hold harmless clauses, and I have not seen too many, should be removed and the limited liability should be increased from the customary six to twelve months of support fees, to a more significant dollar amount.
• Restrictions placed on the buyer from mentioning the software product name in any format for advertising, marketing or any other purposes, without written permission from the seller. This clause is ridiculous and I presume that’s where the “gag” rules on defect disclosures come from, since I have never seen an explicit line item to that effect. The rather humorous fact is that the vendor usually reserves the right to use the buyer’s name for publicity and marketing purposes. This particular clause should be completely removed, or at the very least changed to only disallow misrepresentation of the relationship between the buyer and the seller.
• Most often the software is warrantied to perform according to the product manuals for ninety days, or not at all, and it is never warrantied to be free of defects or work without interruptions. Would you buy a car with a similar warranty? In all fairness, no software vendor can warranty that the product is “bug free”, because there is no such thing as bug free software. However, respectable vendors in the software industry offer Service Level Agreements (SLAs) outlining processes and timelines for addressing reported issues and financial penalties to the vendor for failing to do so. This brings us to the next salient point.
• Some initial EHR contracts lack any mention of SLAs. There may be descriptions of help desk availability, but no commitments to time frames for resolution and definitely no penalties for non-adherence to SLAs. The buyer must be able to negotiate those into the contract or look elsewhere for software and services.

Contracts containing terms as those described above are examples of a typical purveyor of goods and services trying to make a “good deal” and the buyer’s job is to bargain the terms down to what would be a “good deal” for the buyer, with the final result being somewhere in the middle. Ethical considerations would come into play only if the vendor is knowingly proposing to sell goods that will harm patients, and the buyer knowingly agrees to keep this information secret in return for financial concessions from the vendor, and some of the more vocal opponents of HIT would argue that this is indeed the case. But even then, I seriously doubt that such collusion to disregard patients’ safety for pure monetary gain is a result of vendors and their customers not knowing the difference between right and wrong, or lacking a sound education in the realm of Ethics. Nothing short of legislation and regulation will stop this blatantly predatory behavior if it indeed exists, and I doubt it does.

I would like to submit that there is indeed a need for education, but of a very different nature. Whether the vendor and purchaser agreed to keep issues secret or not, the bugs or defects that can potentially harm patients are the creation of software developers on the bottom of the corporate totem pole. These are not unethical folks and have nothing to gain from cutting corners and endangering people’s lives. But just like physicians sometimes make mistakes, programmers do too and what is most frustrating here is that they don’t even have to make a mistake in order to create a clear and present danger in the software. These mostly young and healthy professionals know very little about the practice of medicine and in many cases have no overarching understanding of the product they are helping to build. They may be experts at the tiny piece they were tasked to develop, but few if any have a grasp of the dire consequences caused by an incorrectly sorted list of medications, for example. The bigger the shop and the more geographically dispersed, the bigger the problem becomes. It is tempting to argue here that EHRs should be designed and built by clinicians, like VistA supposedly was. While clinicians should have much input in design and particularly in acceptance testing of EHRs, it is not economically (or socially) feasible to have hundreds of MDs sitting in little cubbies, writing code for a living. Instead, EHR vendors should indeed engage in educating their workforce, including the most junior developers, on how medicine is practiced. They need not become expert diagnosticians, but it would be great if medical software developers would be required to take rotations (similar to residents) at implementing and supporting the software, preferably at customer sites, before being allowed to touch the code.

Success is brought on by doing the little things right. While there may be some ethically challenged industry captains engaging in questionable contracting practices, the armies of people who do the actual work and create the actual products are by and large capable of telling right from wrong and need no lectures on Ethics. What they need is for someone to compel their employer to invest in their professional education so they are able to do the millions of little things right. And I have seen enough young software developers to know that they really, really want to learn and do the right thing.

Quiz

Below are several random verbatim (vendor name removed) quotes from EHR vendors’ websites or press releases.


Question: What do the following EHRs have in common?


 
ABCD EHR has earned the distinction of receiving ONC-ATCB certification. ABCD is at the forefront of the effort to help providers across the US to become “meaningful users” of EHR and qualify for $44,000 to $63,750 in federal stimulus dollars. The eligible professionals and hospitals can use this certified EHR technology as part of their criteria to qualify for Center for Medicare and Medicaid Services (CMS) incentive payments.

Using our EMR System qualifies you for $44,000 in economic stimulus plan incentives under the HITECH Act. Visit our Stimulus Center.

"EFGH-EHR is meeting all of the requirements for 'meaningful use', which means you will be eligible to get your share of the government incentive with EFGH-EHR".

JKLM announces that the JKLM EMR has been tested and certified under Drummond Group's Electronic Health Records ONC-ATCB program (ONC-ATCB EHR 1234567890). Drummond Group Inc. is an ONC authorized testing and certification body (ONC-ATCB) that provides meaningful use certification for EHR systems and applications. When a complete EHR system or EHR module(s) is certified by Drummond Group, the eligible providers and hospitals can use this certified EHR technology as part of their criteria for qualifying for Center for Medicare and Medicaid Services (CMS) incentive payments.

NOPQ, (www.NOPQ-website.com), one of the nation's top independent medical healthcare information technology companies, has received an EHR module certification deeming the electronic health record (EHR) software capable of enabling providers to meet the Stage 1 meaningful use measures required to qualify for funding under the American Recovery and Reinvestment Act (ARRA).

Answer: None of the certified products above, in their current state, will qualify you for Government incentives, since none of these products have been certified as a “Complete EHR”.

If you are shopping for an EHR and if you are interested in qualifying for incentives for Meaningful Use, please visit ONC’s listing of certified HIT products at http://onc-chpl.force.com/ehrcert . Once there, make sure that your selected EHR has “Complete EHR” specified in the “Product Classification” column. Anything with “Module” in that column will require that you purchase additional products to qualify for incentives. Make sure that the version you are about to purchase matches the entry in the “Product Version #” column as well.

Additional word of advice: Even if the EHR you are considering is certified as “Complete EHR”, ask to see a detailed demo of each one of the 25 Meaningful Use Stage 1 criteria and make sure that all the functionality you are seeing is included in the price you were quoted.

As usual, Caveat emptor is the name of the game…..

It’s the Network, stupid

So November 2nd came and went and the GOP has done well and media of every form and shape is trying to predict the fate of health care reform. Uncertainty looms large over the Affordable Care Act, but there is one tiny bit of it that has gathered enough momentum during the last two years to be unstoppable and irreversible. Health Information Technology (HIT) has made it over the tipping point and its dependency on Government support is no more.

The skeptics and those opposing HIT in general, will be pointing out that if the new-and-improved Government finds a way to reverse the flow of billions of dollars initiated by the HITECH act, all activities will come to a grinding halt. No more Meaningful Use and no more State HIE and no more RECs evangelizing for adoption of EHRs and, most importantly, no more cash incentives for physicians to buy those pesky EHRs. Surely all health care providers will turn back to their voluminous paper charts with a sigh of relief and a gleeful “I told you so”. And perhaps some will, but not many and not for very long.

With or without Government involvement, the health care fundamentals remain unchanged. Health care is too expensive for most Americans and anyone selling health care services will have to find a way to manage costs down if they are to stay in business. Hospitals and large systems have recently made astronomic investments in HIT. These cannot be ripped out and written off as easily as one may imagine. The logical path for these large providers is to compensate for potential loss of incentives by finding other returns for their investments. Perhaps CPOE and reporting of convoluted quality measures will be taking a backseat to measuring efficiency and cost-effectiveness. Since keeping folks healthy in the first place seems cheaper than managing diseases and complications, perhaps longitudinal health management and coordination of services will become a major priority. To keep profitability up in a market where most people are non-consumers (the GOP way), or a highly regulated low-margins market (the Democrats way), health care providers will be competing for every bit of market share through mergers and consolidations and the creation of Networks. And Networks are powered by HIT.

The Medical Society of Delaware was founded when George Washington was President. Last week, the Society announced the creation of a statewide Network connecting all its members to Delaware patients. Every Delaware resident is provided with free access to a Personal Health Record (PHR) supplied by RelayHealth and in collaboration with LabCorp, Delaware physicians will be sharing lab results with their patients and each other. Delaware is also home to the first operational State Network (2007), the Delaware Health Information Network (DHIN), which connects over 60% of Delaware’s physicians with hospitals, labs and patients and provides a variety of clinical information exchange.

Michigan is kicking off its brand new statewide Network as well. The Physicians’ Organization of West Michigan (POWM) in collaboration with the University of Michigan Health System is creating the Physicians Organization of Michigan (POM), thus “allowing independent physicians to stay independent, rather than at the behest of a large hospital system”. POM is combining resources from two very large organizations to provide physicians and physician groups across Michigan with “access to resources, opportunities and support that will allow them to remain independent while adapting to the new health care environment”. This of course includes “access to shared technology systems and a framework for measuring and improving the quality of the care they provide”.

On the vendor side, eClinicalWorks (eCW) unveiled its 100millionpatients.com Patient Portal to complement the Peer-to-Peer (P2P) community Network spanning all eCW users, and to some degree practices that are not eCW customers. Within the eCW P2P Network, physicians can exchange referrals (summaries, results and all sorts of documents), schedules and demographics, with a click of a button. The new PHR will presumably give patients similar cross Network access. And then, there is Surescripts, with its Network of over 150,000 prescribers, 85% of pharmacies and 65% of patients. Recently Surescripts decided to expand beyond prescriptions and make its Network available for exchange of a wider variety of clinical information. This is a national Network and judging by its current practices, Surescripts will be offering a completely open and standards based Network to all HIT vendors, and their customers, wishing to connect and exchange clinical information. Another prominent Network operator, NaviNet, has recently announced its intent to embed a fully certified EHR in its largely administrative Network of hundreds of thousands of providers.

There are many more such Networks being created, extended and deployed all over the country. What do all these Networks have in common? They are not supported by Government funds. These are private investments in clinical information exchange. Most of these Networks can afford to provide connectivity to both patients and providers for nominal prices, or completely free, since their revenues will be coming from secondary sources, such as referrals, payers, pharmacies and data mining. If the financial HITECH fountainhead is shut off by the new realities in Washington (not very likely), or throttled back somewhat (probably), these market driven Networks will be only minimally affected. HIT is here to stay. For all those who are skeptical or downright opposed to HIT, please look back at each and single technology in use today and understand that technology only moves in one direction: forward.