Legal and ethical considerations of artificial intelligence in skin cancer diagnosis.

Artificial intelligence (AI) technology is becoming increasingly accurate and prevalent for the diagnosis of skin cancers. Commercially available AI diagnostic software is entering markets across the world posing new legal and ethical challenges for both clinicians and software companies. Australia has the highest rates of skin cancer in the world and is poised to be a significant benefactor and pioneer of the technology. This review describes the legal and ethical considerations raised by the emergence of artificial intelligence in skin cancer diagnosis and proposes recommendations for best practice.

Are Current Tort Liability Doctrines Adequate for Addressing Injury Caused by AI?

As capabilities of predictive algorithms improve, machine learning will become an important element of physician practice and patient care. Implementation of artificial intelligence (AI) raises complex legal questions regarding health care professionals' and technology manufacturers' liability, particularly if they cannot explain recommendations generated by AI technology. The limited literature on liability for innovation provides opportunities to consider possible implications of AI for medical malpractice and products liability and new legal solutions for addressing liability issues surrounding "black-box" medicine.

Medical Devices; Neurological Devices; Classification of the Computerized Cognitive Assessment Aid. Final order.

The Food and Drug Administration (FDA) is classifying the computerized cognitive assessment aid into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the computerized cognitive assessment aid's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

[Proposal of a computerized method to assess work related stress according to legal requirements in Italy]. / Aggiornamento delle Linee di indirizzo della Regione Toscana sullo stress lavoro-correlato. Realizzazione di un software per l'applicazione facilitata del modello di valutazione proposto alla luce delle indicazioni tecniche del documento di coordinamento tecnico delle regioni.

Assessing psychosocial factors in occupational environment requires complicated procedures according to most methods. The project of Tuscany region has the aim to realize a free computerized instrument for a gradual risk assessment with two different modes, expert and beginner. A decisional flow chart helps to approach the risk assessment step by step on the basis of company features, management and organization problems and company symptoms of stress. This experience means a proposal of a computerized method for a quantitative assessment of psychosocial risks at workplace, but at the same time offers a detailed analysis of the problems in the organization suggesting different priority to solve them.

The Pap smear, automated rescreening, and negligent nondisclosure.

A new element in the Papanicolaou smear liability crisis is the recent US Food and Drug Administration approval of 2 automated rescreening devices. Their manufacturers have undertaken aggressive advertising in medical journals and in women's magazines, generating controversy about whether this positions such devices as the new standard of care and whether failure to offer such rescreening might lead to liability alleging to tort of negligent nondisclosure, with contributing opinions from pathologists' and manufacturers' counsels. Cases are cited in prenatal diagnostics and blood banking that established liability for failing to disclose diagnostic modalities used by at most only a minority of practitioners and, therefore, have not yet achieved standard-of-care status. It is concluded that informed consent for cervicovaginal smears should include disclosure of the availability of automated rescreening to reduce negligence liability.

Digital imagery/telecytology. International Academy of Cytology Task Force summary. Diagnostic Cytology Towards the 21st Century: An International Expert Conference and Tutorial.

ISSUES: Optical digital imaging and its related technologies have applications in cytopathology that encompass training and education, image analysis, diagnosis, report documentation and archiving, and telecommunications. Telecytology involves the use of telecommunications to transmit cytology images for the purposes of diagnosis, consultation or education. This working paper provides a mainly informational overview of optical digital imaging and summarizes current technologic resources and applications and some of the ethical and legal implications of the use of these new technologies in cytopathology. CONSENSUS POSITION: Computer hardware standards for optical digital imagery will continue to be driven mainly by commercial interests and nonmedical imperatives, but professional organizations can play a valuable role in developing recommendations or standards for digital image sampling, documentation, archiving, authenticity safeguards and teleconsultation protocols; in addressing patient confidentiality and ethical, legal and informed consent issues; and in providing support for quality assurance and standardization of digital image-based testing. There is some evidence that high levels of accuracy for telepathology diagnosis can be achieved using existing dynamic systems, which may also be applicable to telecytology consultation. Static systems for both telepathology and telecytology, which have the advantage of considerably lower cost, appear to have lower levels of accuracy. Laboratories that maintain digital image databases should adopt practices and protocols that ensure patient confidentiality. Individuals participating in telecommunication of digital images for diagnosis should be properly qualified, meet licensing requirements and use procedures that protect patient confidentiality. Such individuals should be cognizant of the limitations of the technology and employ quality assurance practices that ensure the validity and accuracy of each consultation. Even in an informal teleconsultation setting one should define the extent of participation and be mindful of potential malpractice liability. ONGOING ISSUES: Digital imagery applications will continue to present new opportunities and challenges. Position papers such as this are directed toward assisting the profession to stay informed and in control of these applications in the laboratory. Telecytology is an area in particular need of studies of good quality to provide data on factors affecting accuracy. New technologic approaches to addressing the issue of selective sampling in static image consultation are needed. The use of artificial intelligence software as an adjunct to enhance the accuracy and reproducibility of cytologic diagnosis of digital images in routine and consultation settings deserves to be pursued. Other telecytology-related issues that require clarification and the adoption of workable guidelines include interstate licensure and protocols to define malpractice liability.