Medicolegal and regulatory aspects of whole slide imaging-based telepathology

Telepathology is lauded for its potential to overcome geographic barriers and bring expert diagnostic opinions to underserved regions. However, the legal and regulatory aspects governing its use in the United States and abroad are disparate and incomplete. In addition, there is essentially no case law that specifically addressed telepathology. Important issues to consider for the implementation and practice of telepathology, including state and regional licensure requirements, credentialing and privileging, liability and medical malpractice coverage, privacy and security, medical device regulation, and reimbursement for services are reviewed here for several regions, including the United States, Canada, the European Union, and China.