Industry Regulations Flashcards

The Bolam test (Bolam v Friern HMC [1957]) is used in UK medical law to assess which of the following?

Answer: Whether a doctor's conduct met the standard of a responsible body of medical opinion

The Bolam test asks whether the defendant acted in accordance with a practice accepted as proper by a responsible body of medical practitioners skilled in that field.

The Montgomery v Lanarkshire Health Board [2015] Supreme Court ruling changed UK law regarding which aspect of medical practice?

Answer: Informed consent — shifting from the Bolam standard to a patient-centred standard

Montgomery established that doctors must disclose material risks that a reasonable patient in that individual's circumstances would want to know, replacing Bolam for consent.

Under the Medicines Act 1968 and subsequent regulations, which of the following is a Prescription Only Medicine (POM) restriction?

Answer: POMs can only be supplied on the prescription of an appropriate practitioner

By definition, a Prescription Only Medicine can only be supplied to a patient against a valid prescription from an appropriate practitioner.

Which Act provides the legal framework for clinical negligence claims against NHS bodies in England and Wales?

Answer: Limitation Act 1980 and common law tort of negligence

Clinical negligence is pursued under common law tort principles; the Limitation Act 1980 governs time limits, generally three years from the date of knowledge of harm.

The CQC's inspection framework rates providers on a four-point scale. Which rating indicates the most serious level of concern requiring immediate regulatory action?

Answer: Inadequate

CQC uses four ratings: Outstanding, Good, Requires Improvement, and Inadequate — 'Inadequate' is the lowest tier and triggers the most urgent enforcement action.

Under the Freedom of Information Act 2000, which exemption most commonly applies when an NHS trust refuses to disclose information relating to an individual's personal data?

Answer: Section 40 — personal information

Section 40 of the FOIA is the absolute exemption for personal data; requests for a third party's personal information are refused because this is governed by data protection law instead.

Which of the following describes the legal standard of proof required in GMC fitness to practise hearings conducted by the Medical Practitioners Tribunal Service (MPTS)?

Answer: Balance of probabilities (civil standard)

MPTS hearings apply the civil standard — balance of probabilities — when determining whether allegations of impaired fitness to practise are proven.