Senate Finance Committee Requests Answers From 3M Regarding Software Complaints

In response to compliants from medical practitioners, patients, and technology engineers that Health Information Technology (HIT) and Computer Physician Order Entry Systems (CPOE) software programs are often faulty and that the manufacturers' shift blame to the medical facility when errors are found, Senator Grassley, on behalf of the Senate Finance Committee, sent a letter on October 16, 2009, to the CEO of 3M Company requesting information and documentation about 3M's software policies and programs.

Specifically, the letter requested information regarding whether 3M relies on a legal doctrine known as "learned intermediaries" and includes "hold harmless" and "gag order" provisions in its contracts with providers. "Learned intermediaries" shifts responsibility for errors in the HIT systems to physicians, nurses, pharmacists, and other health care providers. It has been reported that manufacturers of HIT systems, like 3M, argue that the health care provider should be able to identify and correct errors caused by the software; thus often include in contracts with medical facilities "hold harmless" provisions that absolve manufacturers of these products of any liability for errors that are allegedly HIT/CPOE system or software failures. These contracts may also include "gag orders," which prohibit health care providers from disclosing system flaws and software defects.

Even more concerning was the report to Senator Grassley that there is no system in place to track, monitor and report the performance of these systems/devices, which could impact a health care provider's ability to make informed decisions regarding the implementation of an HIT/CPOE system.

With Health Care Reform legislation pending, HIT will become a larger investment for the American taxpayers; thus the Senate Finance Committee wants to ensure their monies are going to effective HIT systems and devices.

Many in the health care industry consider these questions long over-due because without transparency of the HIT/CPOE systems and devices it seems unrealistic that medical providers would easily be able to identify errors in these systems. Further, without the risk of liability if the manufacturers' "black box" HIT/CPOE systems contain errors, no incentive exists to improve these software products.

3M must respond to this letter by November 6th, 2009. To see the full list of questions posed to 3M and the original letter, go to the following web site: http://s.wsj.net/public/resources/documents/WSJ_Letter_3M_Company_2009-10-16.pdf.

Let us know what you think of the Senator's letter and whether you are concerned about the accuracy of your HIT/CPOE systems and devices.