Digital Health CQC Governance & Regulatory Advice
Oxara Consulting provides regulatory, governance and operational advisory to CQC-regulated healthcare delivered through remote, online or digitally enabled clinical pathways — establishing whether governance, clinical oversight and evidence match what is actually being delivered.
When digital healthcare needs regulatory input
- launching a new online or remote clinical service;
- changing an existing digital clinical pathway;
- uncertainty about registration, regulated activities or locations;
- introducing or reviewing remote prescribing;
- preparing for CQC scrutiny;
- governance that has developed piecemeal as the service has grown.
Regulated care, delivered through a different channel.
CQC regulates providers delivering a regulated activity through online means — what it terms Online Primary Care Services — including consultations by video or phone and the prescribing of medicines in response to online forms. The regulatory framework is the same Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 that applies to any registered provider; the delivery channel changes what has to be evidenced, not whether it has to be evidenced.
Digital healthcare can involve regulated activities including remote clinical advice, triage, treatment, diagnosis and prescribing. Remote prescribing requires appropriate clinical and medicines governance, and depending on the operating model, pharmacy regulation and professional regulation may also be relevant.
Where a digital or remote care model's registration, governance or prescribing arrangements need to be established, a director can discuss the position.
Discuss Your Digital ServiceGovernance tested against how care is actually delivered.
Oxara examines:
- service model and regulated activities;
- clinical governance;
- prescribing and medicines arrangements where relevant;
- workforce and clinical accountability;
- escalation and safeguarding;
- records and regulatory evidence.
The question is the same one Oxara applies elsewhere: does what is written match what is actually happening in the pathway?
Where specialist pharmacist input is required — for remote prescribing, medicines governance, prescribing pathways or related regulatory matters — Oxara brings in a highly experienced senior pharmacist to work alongside the director leading the engagement, within the same director-led model.
Clarity on the regulatory position, gaps and priorities
- the regulatory position;
- material governance gaps;
- evidence requirements;
- priority actions;
- implementation recommendations where instructed.
Digital healthcare regulatory support across two critical areas
Online Primary Care is for providers delivering consultations, assessment or treatment remotely where identity, safeguarding, continuity and clinical governance must be demonstrable. Remote Prescribing & Medicines Governance is for prescribing pathways and medicines arrangements requiring defensible clinical and governance oversight.
Online Primary Care
Regulatory and governance advisory for providers delivering primary care through online and remote means, where identity verification, clinical governance, safeguarding and continuity of care have to be demonstrably in place.
Remote Prescribing & Medicines Governance
Regulatory and governance advisory for remote prescribing pathways, medicines governance arrangements and the clinical and prescribing oversight that supports them.
The same regulatory foundations apply across Oxara's work.
Registration and variation questions for digital and remote delivery models are covered under CQC Registration & Variation. Regulation 17, Good Governance, and CQC scrutiny and enforcement are set out under CQC Enforcement Support. Where governance needs strengthening ahead of scrutiny, Governance Strengthening & Well-Led Compliance sets out that route. Where a transaction, investment or acquisition requires independent examination of a digital healthcare target's regulatory position and operational risk, Digital Healthcare Regulatory & Operational Due Diligence sets out that scope.
Know what your governance demonstrates before regulatory scrutiny tests it.
Disclaimer
Oxara Consulting is a professional consultancy, not a legal firm. Please see our full Disclaimer for more information.