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Legal and regulatory issues related to the use of clinical software in the health care delivery. 20.1 Introduction. How the legal system, through tort law, may impose responsibility on software vendors and their users for possible harm that medical software might cause to patients
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Legal and regulatory issues related to the use of clinical software in the health care delivery
20.1 Introduction • How the legal system, through tort law, may impose responsibility on software vendors and their users for possible harm that medical software might cause to patients • Highlight ways that institutions’ internal governance can minimize such harm
20.2 Legal issues related to using embedded and free-standing decision support software in clinical settings • legal liability for injuries resulting from use of computer software in health care • Two decades ago, in an article in the Annals of Internal Medicine • To date, no American courts have elucidated the conditions under which vendors, care-providing institutions, or clinicians nurses) might be liable for harm to patients arising from the use of computer software • But given these trends, it seems likely that courts may soon address the issue
The issue of liability arising from the medical use of software programs • Negligence • defendants are liable for unintentionally causing a plaintiff’s injuries where the defendant caused such injuries due to wrongful or unreasonable conduct • Strict liability • merely requires proof that the defendant’s conduct was the direct cause of the plaintiff’s injuries • In the past several decades, the principle of strict liability has been extended to situations where a manufacturer’s product ends up harming the consume
Rationales for strict liability for harms caused by products include: • That consumers have imperfect information and cannot adequately assess a product’s safety on their own • That manufacturers use their market power to rely on standard form contracts protecting themselves from liability • That manufacturers are the most preventable parties, whereas preventing consumers from experiencing accidents would be difficult • Where the accident is not preventable, manufacturers should be held liable because they can spread the risk of the product through pricing mechanisms
The authors conclude that • although products liability may be an appropriate means of holding vendors responsible for defects in medical device software, it should not be applied to most decision support situations.
20.2.1 Software used in medical devices • Catastrophic errors include • a defect in the embedded software that regulates cardiac pacemaker function, • software errors (‘‘glitches’’ or ‘‘bugs’’) that misreport life-critical serum chemistry test results from a laboratory system to an electronic medical record system, and • a programming error in an electronic prescribing system that alters intended doses in prescriptions written by doctors in a manner not readily apparent to the physicians.
In situations involving software-based malfunctions in a clinical context, it seems appropriate to hold vendors accountable through products liability. • The application of such a standard in this context comports with the general purposes behind products liability, because in this type of situation the vendor is uniquely situated to control possible malfunctions
20.2.2 CDS software used by licensed practitioners during medical practice • Two possible scenarios for liability • Reliance upon erroneous clinical advice provided by such software • Failure to use CDS software when its use would have prevented improper treatment of the patient
Erroneous information provided by CDS software • CDS software is unlikely to be considered a product for purposes of products liability
Decisions relating to whether something is a product for purposes of products liability have long distinguished between harms arising from the functionality of a thing and the ideas it contains. • The former is generally classified as product, the latter is not
Thus, CDS software generally can be distinguished from software within medical devices • Medical devices can be classified as products because their tangible effects, such as targeted radiation, are the source of patients’ injuries • CDS software, however, does not replace the judgment or the functions of a physician • It augments the physician’s existing knowledge by providing further information
Negligence appears to be the appropriate standard with respect to vendor liability for nondevice-related CDS software • Physicians (and the hospitals that employ them) may be considered negligent if they fail to question erroneous advice given by CDS software and proceed to provide improper care to the patient
20.3 Responsibility for CDS software at the institutional level and potential governmental regulation • The complexity of institutional clinical software environments • Past and current FDA regulation of clinical software systems
20.3.3 1997 health care and informatics consortium recommendations
Conclusion • Both products liability and negligence may be applicable legal standards of liability for software used in a clinical context • Given the complexity of current programs and aspects of programs that resemble both goods and services, we conclude that the applicability of these differing standards may depend on the particulars of the relevant software • It is likely that clinical software embedded in medical devices in general will be held to strict products liability standards, whereas CDS software that provides advice to licensed practitioners will be judged by negligence standards.
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