Clinical decision support liability

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Information-based liability is an important issue for all clinicians. The rapid expansion of medical information databases, electronic health records and associated medical expert systems and decision support systems has significant potential for impacting medical malpractice. As long as 25 years ago it was realized that availability of computerized medical databases would likely erode the local or community standard of care.

Introduction

It was recognized that physicians would increasingly rely on these databases and computer-based management of biomedical information. Some experts felt that it was logical to assume that courts would hold physicians accountable for the entirety of information available in computerized databases and to expect clinicians to demonstrate a level of decision-making and judgment consistent with available technology.

Physician liability

Patient suits could be generated from injuries resulting from defects in computer function or programming and be based on strict product liability. Others felt that medical databases and clinical decision support systems would be viewed as tools used by a clinician and not a patient-owned product. In this case negligence principles applicable in other medical malpractice actions would apply. Physicians could potentially be held liable for failing to access a computerized medical database, failing to use available software providing decision support, or using this technology in an improper, inexpert or inappropriate fashion.

The proliferation of evidence-based medical software designed to reduce errors, adverse events and presumably improve patient outcomes has exacerbated these concerns. State laws determine the composition of legal medical records, but legislation has lagged behind technological advances and statutes do not generally reflect the current electronic environment. The constitution of the legal record varies from state to state and also institution to institution.

Hospital liability

The content of electronic health records is not defined and it is not clear if manipulation of data or interaction with computer alerts should be included as part of the permanent legal record. Related issues include provider and hospital institutional concerns over the sophistication of current clinical decision support systems, their use as a quality management tool, and concerns about information storage management and security.

Medical professionals rely heavily on access to the most current and relevant information. The exponential growth in available medical information creates significant pressure to better manage this information in the provision of patient care. Point-of-care computerized decision support is currently an important tool in this endeavor. But use of CDSS is currently viewed as the same as the use of medical journal or texts and ensuring the quality of MES or CDSS medical knowledge/evidence databases is extremely problematic.

Causal link between clinician actions and patient outcomes =

Even the most sophisticated clinical decision support systems are unable to establish a causal link between clinician actions and patient outcomes. It’s not currently possible to contextualize CDSS data. Additionally, a number of recent studies have highlighted the possible role of clinical decision support systems in potentiating adverse events, errors and worsened patient outcomes. Clinical decision support system use may negatively influence clinician judgment, promote misuse of information that is not critically evaluated, or be inappropriately used by clinicians not adept at system-user interfaces. CDSSs are a tool that holds great potential promise for improving health care delivery but more outcomes based research is needed to assess the impact of clinical decision support on the delivery of clinical care.

For these reasons clinical decision support systems are not considered the current standard of care and must withstand additional trials and repeated methodological attacks before they become relied upon and associated by the courts with customary practice. Currently, there is little relevant case law in this area. Nevertheless, physicians are likely to be held responsible for the appropriate use and application of clinical decision support systems and should have a working knowledge of the purpose, design and decision rules of the specific decision support systems they use.


References

  1. Bates DW, Teich JM, Lee J, et al. The Impact of Computerized Physician Order Entry on Medication Error and Prevention. J Am Med Inform Assoc. 1999; 6: 313 - 321.
  2. Brannigan A, Dayhoff L. Liability for Personal Injuries Caused by Defective Medical Computer Programs. AM J L & Med. 198; 7: 123 – 137.
  3. Fox J. Clinical Decision Support Systems: A Discussion of Quality, Safety and Legal Liability Issues. Proceedings AMIA Annual Symposium 2002. 265 – 269.
  4. Quality, and Liability. JAMA. 1999; 282(15): 1466 – 1471.
  5. Kacmar DE. The Impact of Computerized Medical Literature Databases on Medical Malpractice Litigation: Time for Another Helling vs. Carey Wake-up Call? Ohio State Law J. 1997; 58: 617 – 654.
  6. Kibble-Smith B, Hafner AW. The Effect of the Information Age on Physician’s Professional Liability. Depaul Law Review. 1986; 39: 69 – 94.
  7. Miller RA, Gardner RM. Summary Recommendations for Responsible Monitoring and Regulation of Clinical Software Systems. Ann Intern Med. 1997; 127(9): 842 – 845.
  8. Rollins G. The Prompt, the Alert, and the Legal Record: Documenting Clinical Decision Support Systems. J AHIMA. 2005; 76(2): 24 – 28.

For more information see the OpenClinical website.

Glenn Irwin Jr.