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Telehealth from a regulatory perspective issues include whether certain health applications and software (e.g. wireless monitoring) could fall in the borderline between the definition of a medical device and software. This is a hot topic as the Medical Device Directive 93/42/ EEC was recently amended to make extend the scope to medical software and different EU member states have taken divergent views on the types of software that would be classed as a medical device. Ethics and consent: A brief overview of the ethics of telehealth, including a discussion over informed consent, patient choice, self-care issues, international transfers of data (important if the NHS contractor has a US parent company), data storage (i.e. how long should information/voice messages derived from a telehealth interaction be stored). Discussion on how NHS staff/NHS contractors should seek consent using telehealth applications, focusing on SMS texts, computer software, email messaging and telephone and fax services. Provide an update on general concepts of liability for telehealth providers and cross-border healthcare issues. For example, if a telehealth operator is providing clinical advice to a patient that that operator will owe a duty of care to that patient, which has implications from a liability perspective.

Telehealth from a regulatory perspective, ethics and consent and update on general concepts of liability for telehealth providers