In that article, entitled "Finding a Cure: The Case for Regulation And Oversight of Electronic Health Records Systems", Harvard Journal of Law & Technology 2008 vol. 22, No. 1, they called for premarketing and postmarketing surveillance of healthcare IT, adverse events reporting, and tight regulation as in the medical device and pharmaceutical industries. They summarized and amplified their views in the short piece "Why Electronic Health Record Systems Require Safety Regulation", Bioethics Forum, March 20, 2009.
In a remarkable new followup article entitled "E-Health Hazards: Provider Liability and Electronic Health Record Systems" available here, they expand their case in a highly organized and extremely well documented piece. The abstract is as follows:
In the foreseeable future, electronic health record (EHR) systems are likely to become a fixture in medical settings. The potential benefits of computerization could be substantial, but EHR systems also give rise to new liability risks for health care providers that have received little attention in the legal literature. This Article features a first of its kind, comprehensive analysis of the liability risks associated with use of this complex and important technology. In addition, it develops recommendations to address these liability concerns. Appropriate measures include federal regulations designed to ensure the quality and safety of EHR systems along with agency guidance and well crafted clinical practice guidelines for EHR system users. In formulating its recommendations, the Article proposes a novel, uniform process for developing authoritative clinical practice guidelines and explores how EHR technology itself can enable experts to gather evidence of best practices. The authors argue that without thoughtful interventions and sound guidance from government and medical organizations, this promising technology may encumber rather than support clinicians and may hinder rather than promote health outcome improvements.
They point out that:
EHR systems can facilitate access to patients’ medical records, improve the quality of care and the accuracy of treatment decisions, achieve cost savings, and promote clinical research. Without discounting any of these potential benefits, this article focuses on the risks of EHR systems and on liability concerns associated with their use ...
The liability risks of EHR systems have received little attention in the legal literature. This new technology may bring with it novel responsibilities, burdens, and complexities for medical practices at the same time that it can potentially enhance health outcomes.
The liability risks are not just to hospitals, but to EHR users of all stripes. They find current efforts at HIT "certification" severely lacking in usefulness, and strongly support federal regulation of health IT due to the risks and dangers involved. The authors are opposed to vendor "hold harmless" and "defects nondisclosure" clauses, and have included in their article many well thought out solutions to the double-edged sword that HIT represents.
In summary, though, they believe that:
EHR systems cannot remain unregulated and largely unscrutinized. It is only with appropriate interventions that they will become a much-hoped for blessing rather than a curse for health care professionals and patients.
Download the article at this link. Read the whole thing.
I am in strong agreement with their positions. The unregulated free-for-all that has been the health IT marketplace, with dangerous and even outrageous practices I noted starting a decade ago, must come to an end as the market matures and as diffusion of this technology massively increases per the government mandates now in effect.
The rationalizations for problems, the excuses for defects and the starry eyed utopian exuberance about this technology (not to mention the conflict-of-interest and/or HIT lobby-driven irrational exuberance) must come to an end.