Friday, March 20, 2009

Let's Deregulate Pharmaceutical Information Technology

... after all, a full Electronic Medical Record/Order Entry/Decision Support system is far more complex, with potential for far more immediate patient impact, then pharma's research IT systems. Yet the former is unregulated.

PhRMA, you should start lobbying to create your own private Certification Commission For Pharmaceutical IT (CCPIT) now. You can start certifying all your IT by going through a checklist of features, and avoid those pesky FDA inspections just as hospital do!

Seriously, my views are identical to that of Hoffman and Podgurski.

They expressed their views in the article "
Finding a Cure: The Case for Regulation And Oversight of Electronic Health Records Systems", Hoffman and Podgurski, Harvard Journal of Law & Technology 2008 vol. 22, No. 1, and now have summarized and amplified them in the short piece "Why Electronic Health Record Systems Require Safety Regulation", Bioethics Forum, Sharona Hoffman and Andy Podgurski, March 20, 2009.

Emphases mine:

...In light of these risks to patient care, federal regulations must establish rigorous quality control mechanisms. Currently, initial approval of EHR systems is conducted by a certification program operated by the Certification Commission for Health Information Technology, a private, industry-based organization. Our review of the certification criteria revealed that they are inadequate to ensure the safety and efficacy of EHR systems . For example, testing is conducted in just one eight-hour period , and the criteria do not explicitly address important issues such as safety and usability.

We believe that EHR systems should be scrutinized through a careful premarket approval process, including field testing at several facilities for at least six months. We also recommend local system oversight committees, based on the IRB model , that would oversee field testing and conduct postmarketing monitoring throughout the life of the product. Adverse event reporting would be mandated under this system to ensure that problems are detected and addressed swiftly and that the government intervenes when necessary to safeguard patient welfare.

Federal regulations should also require that all EHR systems meet specific quality standards. Audit trails and capture-replay capabilities should be required to facilitate discovery of both system and user errors, much as black boxes allow the reconstruction of conditions that led to aviation incidents .

... Because EHR systems will manage patient care to a significant degree, they must be subject to government oversight akin to the highest level of scrutiny required, in principle, by the Food and Drug Administration for complex medical devices ... Federal regulations should establish appropriate oversight and quality control through EHR system standards, approval processes, and ongoing monitoring requirements. It is only with careful oversight that providers can be assured of investing in high quality EHR products. And it is only with appropriate safeguards that the benefits of this very promising technology will be maximized–that health outcomes will improve and risks as well as costs will decline.

I do not think these suggestions are unrealistic.

After spending considerable time in pharma, to be consistent I say either we discontinue FDA regulation of pharma clinical IT, or we continue to regulate pharma's IT and add the even more complex provider healthcare IT to the pool of regulated medical devices.

-- SS

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