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In The Hot Seat Again: eClinicalWorks Faces Billion-Dollar Suit Over Alleged Software Problems

Posted on November 27, 2017 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

Earlier this year, eClinicalWorks agreed to pay $155 million to the U.S. Department of Justice to resolve allegations that it had faked its conformance with Meaningful Use criteria. The DoJ suit alleged that by withholding information needed for certification, eCW violated the False Claims Act.

Now, the vendor is facing what could be an even more serious legal threat, according to a news report appearing in Becker’s Hospital Review. BHR is reporting administrator of the estate of a deceased cancer patient is suing the vendor over data display errors that may have affected the patient’s care.

What makes the stakes so high in this case is that the complaint is asking the court to certify the case as class action, with members to include “all persons residing in the United States whose physicians used eCW to record and store their medical records at all dates relevant.” The suit is asking the court to award plaintiffs $999 million in damages, Becker’s Hospital Review reports.

According to the complaint, which was filed by Kristina Tot, administrator of the estate of the deceased Stjepan Tot, errors with eCW software began to appear before the cancer patient’s death. For example, “he was unable to display his medical history or progress notes,” the complaint reportedly states.

The cancer patient’s problems were far from unique, however, the suit asserts. According to the complaint, important eCW software functions didn’t work or violated regulatory guidelines. The filing claims the vendor didn’t provide accurate and reliable health information, displayed incorrect panels and didn’t record EHR user actions in audit logs.

The bottom line, the suit claims, is that millions of patient records were compromised, leaving patients and physicians unable to rely on the eCW platform.

I am not qualified to speak on whether there’s any merit to the latest suit against eCW, though I think it’s reasonable to assume that the company may not have its act together. (You might also want to check out the angry eCW critiques on this site — whose publisher, like our fearless leader John Lynn, I know to have an impeccable reputation for honesty.)

Ultimately, it’s hard to say whether this latest suit is largely blowback from the previous certification problem or yet another (extremely) costly headache. Either way, if I were part of its leadership team I’d be more than a little shaken by recent events even if the recent complaint gets dismissed.

IBM Works To Avoid FDA Oversight For Its Watson Software

Posted on October 25, 2017 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

I live in DC, where the fog of politics permeates the air. Maybe that’s given me more of a taste for political inside baseball than most. But lest the following story seems to fall into that category, put that aside – it actually involves some moves that could affect all of us.

According to Stat News, IBM has been lobbying hard to have its “cognitive computing” (read: AI) superbrain Watson exempt from FDA oversight. Earlier this year, eight of its employees were registered to lobby Congress on this subject, the site reports.

Through its Watson Health subsidiary, IBM has joined the crowded clinical decision support arena, a software category which could face FDA regulation soon.

Historically, the agency has dragged its heels on issuing CDS review guidelines. In fact, as of late last year, one-third of CDS developers were abandoning product development due to their uncertainty about the outcome of the FDA’s deliberations, according to a survey by the Clinical Decision Support Alliance.

Now, the agency is poised to issue new guidelines clarifying which software types will be reviewed and which will be exempt under the provisions of the 21st Century Cures Act. Naturally, IBM wants Watson to fall into the latter category.

According to Stat News, IBM spent $26.4 million lobbying Congress between 2013 and June 2017. While IBM didn’t disclose how much of that spent on the CDS regulation issue, it did tell the site that it was “one of many organizations, including patient and physician groups, that supported a common sense regulatory distinction between low-risk software and inherently higher-risk technologies.”

IBM also backed a bill known as the Software Act, which was opposed by the FDA office in charge of device regulation but backed enthusiastically by many software makers. The bill, which was first introduced in 2013, specified that health software would be exempted from FDA regulation unless it provided patient-specific recommendations and posed a significant risk to patient safety. It didn’t pass.

Now, executives with the computing giant will soon learn what fruit their lobbying efforts bore. The FDA said it intends to issue guidance documents explaining how it will implement the exemptions in the 21st Century Cures Act during the first quarter of next year.

No matter what direction it takes, the new FDA guidance is likely to be controversial, as key regulatory language in the 21st Century Cures Act remains open to interpretation. The law includes exemptions for advisory systems, but only if it’s they allow “health care professional to independently review the basis for such recommendations.”  Lawyers representing software makers told Stat News that no one’s sure what the phrase “independently review the basis” means, and that’s a big deal.

Regardless, it’s the FDA’s job to figure out what key provisions in the new law mean. In the meantime, waiting will be a bit stressful even for giants like IBM. Big Blue has made a huge bet on Watson Health, and if the FDA doesn’t rule in is favor, it might need a new strategy.

Health IT End of Year Loose Ends

Posted on December 13, 2016 I Written By

When Carl Bergman isn’t rooting for the Washington Nationals or searching for a Steeler bar, he’s Managing Partner of EHRSelector.com, a free service for matching users and EHRs. For the last dozen years, he’s concentrated on EHR consulting and writing. He spent the 80s and 90s as an itinerant project manger doing his small part for the dot com bubble. Prior to that, Bergman served a ten year stretch in the District of Columbia government as a policy and fiscal analyst.

In that random scrap heap I refer to as my memory, I’ve compiled several items not worthy of a full post, but that keep nagging me for a mention. Here are the ones that’ve surfaced:

Patient Matching. Ideally, your doc should be able to pull your records from another system like pulling cash from an ATM. The hang up is doing patient matching, which is record sharing’s last mile problem. Patients don’t have a unique identifier, which means to make sure your records are really yours your doctor’s practice has to use several cumbersome workarounds.

The 21st Century Cures Act calls for GAO to study ONC’s approach to patient matching and determine if there’s a need for a standard set of data elements, etc. With luck, GAO will cut to the chase and address the need for a national patient ID.

fEMR. In 2014, I noted Team fEMR, which developed an open source EHR for medical teams working on short term – often crises — projects. I’m pleased to report the project and its leaders Sarah Diane Draugelis and Kevin Zurek are going strong and recently got a grant from the Pollination Project. Bravo.

What’s What. I live in DC, read the Washington Post daily etc., but if I want to know what’s up with HIT in Congress, etc., my first source is Politico’s Morning EHealth. Recommended.

Practice Fusion. Five years ago, I wrote a post that was my note to PF about why I couldn’t be one of their consultants anymore. Since then the post has garnered almost 30,000 hits and just keeps going. As pleased as I am at its longevity, I think it’s only fair to say that it’s pretty long in the tooth, so read it with that in mind.

Ancestry Health. A year ago September, I wrote about Ancestry.com’s beta site Ancestry Health. It lets families document your parents, grandparents, etc., and your medical histories, which can be quite helpful. It also promised to use your family’s depersonalized data for medical research. As an example, I set up King Agamemnon family’s tree. The site is still in beta, which I assume means it’s not going anywhere. Too bad. It’s a thoughtful and useful idea. I also do enjoy getting their occasional “Dear Agamemnon” emails.

Jibo. I’d love to see an AI personal assistant for PCPs, etc., to bring up related information during exams, capture new data, make appointments and prepare scripts. One AI solution that looked promising was Jibo. The bad news is that it keeps missing its beta ship date. However, investors are closing in on $100 million. Stay tuned.