Clinical Risk Management and Compliance

SERVICES

How we can help you

Founded with the mission of bridging gaps in the Digital Health sector, BMS Digital Safety is dedicated to assisting Health IT manufacturers. We also help Health and Social Care organisations in meeting their Clinical Safety Assurance and Compliance requirements.

Clinical Risk Management, the NHS DCB 0129 & 0160 Safety Standards, and DTAC

BMS Digital Safety leverages expert knowledge in clinical risk management. We effectively guide clinicians through the DCB and DTAC compliance requirements.

 

DCB0129 and DCB0160 are essential UK healthcare standards that are crucial to ensuring the clinical safety of health IT systems. DCB0129 focuses on manufacturers, while DCB0160 targets healthcare organisations. Both require rigorous risk assessments to prevent patient harm, ensuring that digital health solutions are safe and effective.

The Digital Technology Assessment Criteria (DTAC) is an NHS framework. It ensures digital health technologies meet clinical safety requirements. It also covers data protection, technical security, and usability standards. It helps healthcare providers evaluate and adopt safe, effective, and user-friendly digital solutions, ultimately improving patient care and operational efficiency.

Artificial Intelligence Education and Regulatory Support

We offer specialist education and awareness of Al safety and regulatory challenges. 

 

Our consultants help you navigate ISO 42007, BS 30440, and the MHRA Software as Medical Device Legislation, ensuring compliance and avoiding pitfalls. 

Consultancy and Retainer Services, Clinical Governance Support and Training​

Experience ongoing, trusted support through our consultancy and retainer services. Benefit from regular engagement, providing crucial input into your projects, ensuring thorough assessment, analysis, and evaluation of design, development, and deployment. 

 

Our dedicated Clinical Safety Officer is at your disposal for consultations and reviews.

 

We are able to support you on this journey. We utilise our experience in both patient safety and clinical medicine to deliver safe and efficient governance systems.

 

We also provide Clinical Safety awareness and Clinical Safety Officer Training.

 

Electronic Patient Record Support

The rollout of Electronic Patient Records (EPR) is gaining pace, and becoming central to the government’s “analogue to digital” NHS transformation plan. This initiative is a hot topic in political, NHS, and clinical circles. Ensuring the safety and assurance of these systems is essential to maintain the confidence of both the public and clinicians. Unfortunately, high-profile lapses have caused reputational damage to the EPR scheme, which we must do our utmost to restore. 

BMS Digital Safety’s group of Clinical Safety Officers and Regulatory Experts have years of combined experience optimising the safety and usability of EPR systems in both the private and public sectors, including NHS Trusts and ICBs across the country. 

ISO Standards and Medical Device Compliance

The health-tech software landscape is rapidly expanding. Understanding the regulatory requirements of your cutting-edge technology is essential. 

 

Our expert consultants provide advice on the latest ISO Standards and Medical Device regulations, assisting you in becoming compliant. 

Design Input from Expert Clinicians

It is crucial to involve clinicians early in health technology development.

 

At BMS Digital Safety our expert team of clinicians can assist you in avoiding the common pitfalls and costly design retrofits; whilst ensuring you meet mandatory safety standards and effectively support healthcare delivery.