Himanshu Desai

Digital systems increasingly influence clinical decisions and patient care.

That creates risks that cannot be assessed through cybersecurity, privacy or technical functionality alone.

Clinical safety considers whether use, misuse, failure or interaction with a system could contribute to patient harm.

This requires understanding:

• Clinical workflows
• Technology
• Human factors
• Hazards
• Controls
• Organisational responsibilities
• System implementation
• Change management

Himanshu brings extensive practical healthcare technology experience to this work.

Clinical Risk Management Standards DCB0129 and DCB0160 form an important part of the assurance environment for health IT in England.

Broadly:

DCB0129 addresses clinical risk management responsibilities for organisations manufacturing or developing health IT systems.

DCB0160 addresses clinical risk management responsibilities for health organisations deploying and using health IT systems.

IG-Smart can incorporate these requirements alongside wider privacy, cyber and regulatory assurance rather than treating clinical safety as a separate exercise.

Himanshu's healthcare technology background includes senior positions such as:

• Head of Pharmacy Information Systems — Sidra Medicine, Doha
• Business Relationship Partner — Sidra Medicine
• Manager, Clinical Applications – Paediatrics — Department of Medical Informatics, Sidra Medicine
• Business Relationship Manager — Royal Brompton and Harefield NHS Trust
• Pharmacy Informatics Consultant — NoemaLife
• Senior Transformation Manager — Guy's and St Thomas' NHS Trust

This breadth provides exposure to both technology implementation and the clinical environments in which digital systems operate.

Health technology rarely creates only one category of risk.

A digital product may need to address:

Clinical Safety

Data Protection

Information Governance

Cybersecurity

NHS Assurance

Supplier Risk

Technology Governance

AI Governance

IG-Smart therefore brings these disciplines together within a wider Health Assurance model.

Himanshu's expertise is particularly relevant to:

• HealthTech suppliers
• Digital health developers
• NHS suppliers
• Clinical software companies
• Healthcare organisations
• Technology transformation programmes
• Electronic patient record programmes
• Clinical applications
• Pharmacy technologies

Clinical safety documentation matters.

But the objective is not the document.

The objective is understanding and controlling the risks that technology may introduce into patient care.

That principle shapes IG-Smart's approach to clinical assurance.

Himanshu can support:

• Clinical safety assessments
• Clinical risk management
• DCB0129 support
• DCB0160 support
• Clinical hazard analysis
• HealthTech assurance
• Clinical system implementation
• Healthcare informatics
• Digital-health transformation