Table 1.
Digital health technology | Technology-specific risk(s): most frequently cited | Author comments on malpractice liability |
---|---|---|
Telehealth | Error in medical diagnosis: ~66% of claims, e.g. due to inability to physically examine a patient and challenges in communicating in a virtual environment | Errors in diagnosis are significant as they are associated with a high proportion of serious injury or loss of life (44% in a US-based study). High proportion claims settled or awarded to plaintiffs (60% in one US-based study). Mitigate through risk informed deployment of technology for specific clinical scenarios only and technology-specific training of clinicians |
CDS tools |
Scenario 1: CDS rightly recommends within standard of care, but clinician does not follow Scenario 2: CDS erroneously recommends outside of standard of care, but clinician follows |
A simulated study of 2000 US-based jurors believed that clinicians should be liable in (1), but perhaps not in (2). Mitigate by addressing ‘black box’ nature of tools, i.e. use tools that provide some level of transparency and reasoning for clinical advice, and through training on uncertainty decision making |
mHealth | Error in clinical decision making based on false diagnosis or false data, e.g. from a remote monitoring device | Decision re liability likely made on a highly fact-specific basis. For example, risk increased if the clinician is shown to have a reason to suspect inaccuracy of the data eg. significant outlier, device prone to collection of incorrect data, other clinical explanation |
EHR | Error in medical diagnosis: ~33% of claims, due to factors such as poor patient communication secondary to screen focus, ‘information bloat’, challenging user interface, lack of skills in utilizing the system, failure of system ‘alarms’ for abnormal data | In a US claims database EHR-related claims tripled from seven cases a year in 2010 to 22 cases in 2017/18. Both user-specific factors eg. skill navigating the systems and technology-specific factors eg. user interface, or system performance relevant for determination of risk. Training on use of specific EHR platforms is important before deployment. Mitigate risk through clinical behavioural changes such as repositioning to optimize communication |
Digitally enabled operating rooms and cross-border telemedicine | Digital surgical platforms lead to challenges in adaptation in terms of technical skills and non technical skills, particularly communication and team work. Telesurgery introduces additional risks for malpractice due to regional and international differences in licensing, regulations and standards of care | Analysis of Bloomberg Law database identified 123 malpractice claims involving robotic surgery between 2000 and 2017. Level of risk dependent on technical skills including surgical skill and experience (documented learning curve). Future risk may be impacted by the growth of ‘ambient recording’ in operating theatres, yielding data that may be used as evidence in context of malpractice claims, and ‘cross-border’ deployment of telesurgery. Mitigate through awareness and understanding of official guidance e.g. American Telemedicine Association |