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Who’s Watching Your Electronic Records?

An article in today’s Boston Globe highlights an enormous, yet little-known problem with the quality of electronic medical records systems that are becoming ubiquitous in the health care industry today.  The problem is that there is no effort whatsoever to regulate or control how these systems are developed, tested, maintained or operated.  Anyone can write an electronic medical records system and start to sell it.

The topic of shoddy systems has been a frequent topic for blogger Scot Silverstein M.D., whose mother died as a result of a programming error in an electronic records system.  There is no oversight, either governmental or private for these systems that affect the lives and health of millions of patients each day.  As a result, systems that are intended to improve care may actually cause errors that lead to injury or death.  These errors may result from programming “glitches” that prevent important data from being transferred from one screen or section of a record to another, that fail to create warnings or alerts as intended, that get dates wrong, permit contraindicated medications to be prescribed, or a host of other issues.

As of now, electronic medical records systems receive very little oversight from the federal government, and the industry wants to keep it that way.  Pending legislation would strip the government of any authority to regulate the records industry.  Unfortunately, there is no central repository for tracking errors or glitches, let alone a registry of patients harmed by medical records errors.  With only anecdotal data available, there is no way for consumers or health care IT managers to assess a software program’s safety record.  The techonology companies claim that government regulation would slow down the process of creating and updating systems, making it more difficult and expensive to implement new software or to fix bugs in existing programs.

But proposals for increased government regulation, particularly by classifying records systems as “medical devices” subject to a host of Food & Drug Administration regulations, are less than ideal as well.  The FDA regulatory system as applied to pharmaceuticals and medical machinery and devices has been a disaster for patients.  The approval process is slow, expensive, and the FDA really doesn’t have the resources or expertise to evaluate drug manufacturers’ safety claims effectively.  And when something goes wrong, federal law in most cases leaves injured patients without a remedy against the manufacturer.  It’s not at all clear that including electronics records systems within the FDA’s jurisdiction would solve more problems than it would create.

One of the major obstacles to safety is that no one knows much about these systems and their everyday effects on patients, and so it is difficult to assess their safety on a large scale.  Once again, trial lawyers may play an important role in the safety effort, by identifying bad systems that lead to bad outcomes, and shining a light on shoddy work.

The difficulty is that the industry, which claims that it should regulate itself, has not done so.  There are no effective standards for these crucial systems, and no review process, data repository, or other attempt to identify large-scale problems.


Who’s Watching Your Electronic Records? | Crowe & Mulvey, LLP