Title Quality, Standards and Legislation
Type Stage Two
Code HBI131
Requirement Compulsory

Module objective

The Clinical Scientist in HSST will be required to lead high-quality, safe physical sciences services to ensure they comply with the requirements of current national and international standards and legislation. Of particular emphasis is the role of standards and legislation in promoting safe, high-quality care for all users of healthcare services.

By the end of this module the Clinical Scientist in HSST will be able to analyse, synthesise and apply their knowledge and understanding of the standards, legislation and guidance relating to: (i) medical devices; (ii) infrastructure and software development; (iii) data security; and (iv) network management in a range of environments, including hospitals, primary care and the patient’s home. They will identify and, where appropriate, contribute feedback during the development of local, national and international standards, and lead their implementation and monitoring in their area of clinical practice.

They will also understand the governance of issues around medical device development and the use and role of standards, legislation, guidance and best practice in providing safe and effective clinical services that use medical technologies. The Clinical Scientist in HSST will understand reporting structures in relation to incidents involving potential breaches of standards, legislation and guidance, including how to manage and investigate the root cause of such incidents.

The Clinical Scientist in HSST will also be expected to consistently demonstrate the attitudes and behaviours necessary for the role of a CCS leading safe, high-quality healthcare services.

Knowledge and understanding

By the end of this module the Clinical Scientist in HSST will be able to analyse, synthesise, evaluate and critically apply their expert knowledge of standards, legislation and guidance, including:

  • Differences between guidance, policy, standards, legislation, directives and regulations.
  • Current local hospital/healthcare policies.
  • Current NHS safety and quality reports and recommendations to support quality of care and patient safety.
  • How to promote a culture underpinned by the NHS Constitution that values quality and safety centred on the patient.
  • Open vs closed standards.
  • Gap analysis.


  • The purpose and structure of a clinical governance framework to unite a range of quality improvement activities to safeguard standards and facilitate improvements in clinical services.
  • The role of risk management in the delivery of a safe, high-quality service.
  • The principles of and need for quality and safety improvement in healthcare.
  • How care plans can be used to improve patient safety.
  • Safety issues in the framework of case-based discussions.
  • Local major incident planning and their potential role in any such incident.
  • The purpose, generation and review of clinical guidelines.
  • The benefits and limitations of guidelines and care pathways.
  • Systems of quality assurance and clinical improvement in clinical and scientific work and training.
  • The quality improvement process.
  • Opportunities for improving the reliability of care following audit, adverse events, or ‘near misses’.
  • Root-cause analysis and its use in physical science services.
  • Importance of reporting, discussing and learning from all incidents and concerns related to patient safety.
  • The audit cycle and how it relates to the improvement of clinical care in physical science services and the wider healthcare environment.
  • Features of an effective audit that lead to real and sustained changes in practice.
  • Certification and accreditation schemes.

Synthesising the relevance of standards and their use in healthcare

  • International Standards, e.g. ISO 9001; 14971; 62304; 27000; 62366; ISO 55000 series; ISO 20000 series.
  • Current National Standards, e.g. deployment of software (ISB0129 and ISB0160).
  • The implications arising from emerging standards such as the ISO 80001 family, involving medical devices on hospital IT networks.
  • Clinical protocols, including the use of DICOM conformance statements and HL7 (both versions 2 and 3) in equipment procurement and integration.
  • Advanced DICOM/Integrating the Healthcare Enterprise (IHE) concepts applied to the specialist area of practice.
  • ICT standards development applicable to healthcare (e.g. DICOM, HL7).
  • Network and communication protocols, e.g. Transmission Control Protocol (TCP) and TCPS (Secure), HTTP, SSH, IPSec.
  • Software engineering principles – the product life cycle, including specification, design, implementation, quality assurance and testing, documentation, upgrade and eventual replacement.

Software standards

  • Software development (e.g. IEC 60101-4, EN ISO 13485, EN ISO 14971, ISO 90003, IEC 62304: 2006, ISO/IEC 8631:1989).
  • Software testing (e.g. ISO29119).
  • Software engineering standards (e.g. ISO 13485: 2012).
  • Software metrics (e.g. IEEE 1061-1992).
  • Software safety standards (e.g. IEC 60601-1-4: 1996, IEC 61508: 2000, IEC 80001-1: 2010, ISO 14971: 2012).
  • Legal implications of software standards.

Legislation and guidance

  • Legislation relating to medical devices, computer instrument development and software development, data security and network management, plus associated guidance documents.
  • Implications of the legal requirements for clinical data storage and archiving.
  • Legislation and guidance relating to:
    • medical devices;
    • infrastructure development;
    • software development;
    • data security and network management.
  • Implications of:
    • non-compliance;
    • legal requirements for clinical data storage and archiving;
    • critical incident reporting.
  • Mechanisms required to maintain privacy, confidentiality, integrity and access for clinical data held electronically, as applied in healthcare.
  • The uses, value and risk in virtualisation and in cloud computing, including third-party storage of clinical data.

Technical and clinical skills

By the end of this module the Clinical Scientist in HSST will be able to demonstrate a critical understanding of quality, standards, legislation and guidance in their area of clinical practice. They will apply their knowledge in their area of Physical Sciences, performing and mastering the following technical and clinical skills, and will be able to:


  • Initiate and lead a system of quality assurance and service improvement in a clinical scientific computing setting.
  • Design, implement and evaluate a quality improvement project and disseminate the findings, instigating changes in practice as necessary.
  • Critically reflect on the challenges of implementing, maintaining and improving services, building on a critique of available evidence base.
  • Identify the need for, undertake and document a risk assessment, and implement the actions of a clinical scientific lead procedure.
  • Evaluate personal learning with respect to quality and safety improvement and the role of audit as part of personal professional development.
  • Ensure that staff and non-staff resources are assessed and deployed to obtain high-quality services while offering best value for money.
  • Lead discussions on improving technical clinical practice in a multiprofessional setting, defending and justifying proposals.
  • Identify opportunities for improving the reliability of the clinical service as an outcome of audit, adverse events, critical incidents, or ‘near misses’, and critically evaluate the impact of each improvement.
  • Actively participate and/or lead trust or directorate audit/clinical governance processes and meetings.
  • Evaluate the recommendations of an audit or health improvement project related to patient safety issues, disseminate findings and introduce improvements into service.

Standards and policies

  • Direct the operation of an area of physical sciences service to ensure compliance with local, national and internationally accepted standards and guidelines.
  • Create, implement and audit compliance with local standards within their own area of practice.
  • Critically review current hospital policies relevant to their work area, identify gaps and contribute to the development of revised or new hospital policies.
  • Lead the implementation of standards, legislation and guidance within an area of the Physical Sciences.
  • Implement a recognised software standard for use within a physical sciences service, including the creation of local rules.
  • Critically evaluate how effectively standards, legislation and guidance are implemented within the organisation; write and publish a report; and present and defend findings and  recommendations.
  • Manage the reporting of non-compliance with standards and investigation of incidents that breach statutory requirements (including root-cause analysis).
  • Generate auditable records of compliance with regulation and standards.
  • Advise on and analyse issues regarding data security.


  • Analyse clinical data transfer processes currently in place or required for higher management and other agencies, including the appropriate use of anonymisation, pseudonymisation, encryption and deletion tools where patient data are concerned, and report on compliance with legislation, standards and guidance.
  • Ensure compliance with the appropriate legislation in commissioning physical sciences services.


  • Ensure physical science services reflect the needs and preferences of patients, their families, carers as well as the public health requirements of the populations they serve.
  • Build links and collaborate widely with users of physical sciences and healthcare science services both internal and external, e.g. innovation partners, research partners.

In addition, Clinical Scientists in HSST will be expected to reflect on the challenges of applying research to practice in relation to these areas of practice and suggest improvements, building on a critique of available evidence.

Attitudes and behaviours

This module has no attitude and behaviours information.


Code Title Action
HBI1-2-20 Clinical Bioinformatics - Physical Sciences [v1] View