March 2011

Editors:
Raymond D. Aller, MD
Hal Weiner

Hold harmless clauses in health care IT contracts: assessing accountability

Just as the market for electronic health record systems is surging, controversy is stirring over what some say are ethical issues surrounding health care information technology contracts. The root of the issue: hold harmless clauses, which essentially absolve vendors of responsibility for errors or defects in their software.

The American Medical Informatics Association has issued a position paper asserting that hold harmless clauses in HIT contracts are unethical. The paper, “Challenges in ethics, safety, best practices, and oversight regarding HIT vendors, their customers, and patients: a report of an AMIA special task force,” has received considerable attention.

Initially released online in late 2010 and published in the January issue of JAMIA (the peer-reviewed journal of AMIA), the paper includes recommendations for revising HIT contracts. The task force recommends that HIT contracts delineate a transparent process for conflict resolution and avoid language that prevents users from disclosing software errors. The paper also calls for HIT vendors, purchasers, and users to under-go ethics training that parallels that required of health care organizations with regard to accreditation, and for the industry to adopt best practices for purchasing and implementing software.

Finally, AMIA says the HIT community should re-examine whether government regulation of electronic health care applications could improve patient care, public health, and patient safety. The position paper states: “The task force recommends that AMIA join with other stakeholders to revisit the role of governmental and other formal regulation and governance of institutions that manufacture and use health information systems—including, but not limited to, electronic health records, personal health records, computerized provider order entry systems, electronic medication administration record systems, and laboratory systems.”

“There’s a crying need for transparency and some empirical work on this,” says Kenneth Goodman, PhD, FACMI, chair of the AMIA special task force and lead author of the position paper, as well as founder and director of the University of Miami Bioethics Program. “I think people crave guidance of this sort,” he continues. “They are glad that professional organizations are tending to ethical, as well as professional, economic, and implementation issues.”

But while some in the health care field assert that hold harmless clauses have no place in HIT contracts because patient safety is involved, others disagree, at least in part.

“A hold harmless clause moves too much responsibility to the hospital side,” says Bruce Friedman, MD, active emeritus professor of pathology at the University of Michigan Medical School, Ann Arbor. However, Dr. Friedman doesn’t understand why ethics should be part of what he says is first and foremost a business issue. “I think AMIA is just confusing the situation by bringing in health ethicists,” he says.

Dr. Friedman is strongly opposed to the concept of government oversight of HIT software. “My objection to that is anytime you have this regulatory oversight, progress stops or slows down considerably,” he says. “In addition, the cost of the product increases because the vendor needs to supplement its regulatory staff.”

CAP TODAY “Newsbytes” contributing editor Raymond Aller, MD, director of informatics in the Department of Pathology, University of Southern California, Los Angeles, agrees that government intervention can be problematic. “I think AMIA and others need to remember the disaster we had in pathology labs with the FDA deciding to regulate blood bank systems” about 20 years ago, Dr. Aller says. “It basically froze progress in blood bank systems for probably five or 10 years. Even now, blood bank systems are not keeping up with other clinical systems because of the way the FDA regulates them.”

Some regulation of HIT software may be necessary, he continues, but free rein should not be given to the FDA or any other agency. “Beware of the law of unintended consequences,” he warns.

Because HIT contracts are confidential, just how prevalent hold harmless clauses have become is not clear. And in a lawsuit involving medical software, any legal settlement will incorporate a nondisclosure clause, says Ross Koppel, sociology professor at the University of Pennsylvania and a coauthor of the AMIA position paper. “The hospital and physician who were involved in a mistake don’t want it publicized; the HIT vendor with the faulty product doesn’t want it publicized; and the harmed patient or his widow has signed a nondisclosure letter as part of the award,” he says.

One laboratory information systems vendor that includes hold harmless clauses in its contracts is ClinLab, Orange City, Fla. Such clauses are common across the information technology industry and are justified, says ClinLab vice president Allen Wilson. The issue, he contends, is that software operates upon layers of information systems from various companies, so pinpointing the cause of data failure can be challenging.

“Anytime you build a software system on top of an operating system/environment like Microsoft, Oracle, et cetera, the application software is quite dependent on underlying layers functioning exactly perfect,” Wilson says. “So even if we de-velop perfect software, we are still dependent on the underlying layers, such as the server, and local operating systems, and network architecture, which are completely out of our control.”

Before AMIA decides whether to pursue the issue of hold harmless clauses further, the association wants to collect additional responses to its position paper, Dr. Goodman says. The feedback so far, he notes, has been overwhelmingly positive. “What you’re seeing is a perfect storm of interest at the intersection of electronic health records, patient safety, and the interactions between the companies that make and sell IT systems and the hospitals and other entities that buy and use them.”

Sunquest expands laboratory product line

Sunquest Information Systems recently introduced its Sunquest CoPathPlus anatomic pathology specimen-management and tracking solution and Sunquest Physician Portal outreach order and results solution. The company also announced that its Sunquest Laboratory 6.4.2 laboratory information system has achieved 2011/2012 certification as a modular electronic health record system in accordance with meaningful use criteria for hospitals.

The company’s CoPathPlus solution is designed to automate the management of anatomic pathology specimens. It features advanced integration with digital imaging.

The Sunquest Physician Portal, a component of Sunquest’s Outreach Advantage suite, allows physicians to electronically enter orders and view results for diagnostic laboratory and radiology tests. The system is fully integrated with Microsoft Health-Vault, so results can be transmitted directly to a patient’s HealthVault record.

Apollo releases cloud-based patient media manager

Apollo PACS is now offering its Apollo Enterprise Patient Media Manager, or Apollo EPMM, as a cloud-based model.

The multitiered, open-system software allows health care organizations, physicians, and allied health professionals to secure, manage, and access clinical multimedia content from their desktops for a subscription fee.

By linking legacy systems across multiple departments and specialties, including pathology, Apollo EPMM can locate, manage, and deliver specialty-specific clinical, multimedia content to any user or group within an enterprise, whether the information is originally stored in silos or a central repository. The product includes rules-based security and audit trail functionality.

Meditech purchases LSS Data Systems

Meditech has acquired LSS Data Systems, its business partner for the past 28 years.

Meditech will offer LSS’ medical and practice-management software as its ambulatory solution for Medi-tech Magic, client/server, and 6.0 health care information system customers.

HHS launches Web portal to support health IT developers

The U.S. Department of Health and Human Services has launched a Web portal that serves as a source of health care data for developers of health information technology.

“The Health Indicators Warehouse provides a new public resource needed to fuel development of innovative information technology applications needed to improve health and health care decisionmaking,” says HHS secretary Kathleen Sebelius.

The warehouse, available at www.healthindicators.gov, includes nearly 1,200 health indicators derived from more than 170 data sources, all of which can be downloaded via application programming interfaces. The portal offers Web 2.0 technology.

SCC recognized for workforce training

SCC Soft Computer has ranked fourth in Training magazine’s “2011 Training Top 125” report. The an-nual report recognizes 125 companies for their achievements in workforce training and development.

SCC is the only health care information technology vendor to be listed in the top 10 companies for four consecutive years.

Contracts

JS Genetics, a diagnostics company with laboratory facilities in New Haven, Conn., has selected the soft-ware-as-a-service provider Xifin to handle its billing, accounts receivable, and revenue cycle management activities.

Bedford, Tex.-based Carter BloodCare community blood center has licensed Mediware Information Systems’ KnowledgeTrak software. The Mediware system provides automated tools to oversee training require-ments, electronically manage documents, and manage competency and compliance certifications across an organization.