OUR AIMS.

At the heart of our mission lies an unwavering passion for patient safety, a commitment to user-centric involvement, and a drive to empower teams to not only meet compliance standards but to harness their expertise for the greater good. We believe in creating a digital environment where safety is paramount, where the patient’s well-being is non-negotiable, and where every team member thrives in a culture of excellence.

But we don’t stop at compliance. We aim to empower teams to thrive within the compliance framework. We’re not just here to check boxes, we’re here to unlock potential. We provide the tools, knowledge, and support necessary for teams to elevate their work, to innovate, and to deliver a better-connected, safer digital environment.

 

Rebecca Wilson, GPHC.
Founder, Director and Senior CSO

FOUNDER.
DIRECTOR.
SENIOR CLINICAL
SAFETY SPECIALIST.

Rebecca developed the clinical risk management process and framework for a mental health trust, from procurement to deployment, she worked with the trusts teams to perform a gap analysis of policies, procedures and implemented clinical safety activities into business as usual process.

 Advocating the standards and reason behind them to the workforce. Historically, Rebecca worked at NHS Digital, as a Senior Pharmacy Technician and a Clinical Informatic for a multitude of national programmes. 

These included Prescribing Data & Integrating Pharmacy Into Other Care Settings, Electronic Prescription Service & Summary Care Record to name a few. Here she worked with strategic teams, working closely with others to input into ministerial papers. Here she qualified in project and programme management, critical government writing and completed the Mary Seacole programme for leaders. This is also where her CSO journey began.

Although a heavy NHS background, Rebecca also works closely with software and app developers and supports them with safe design, developments, testing and release processes. Completing the DCB0129 related documentation she advises, guides and assists the teams, also, ensuring DCB0160 responsibilities are met by deployers, to ensure a clear, defined clinical risk management implementation and maintenance process.
 
Rebecca thrives on working with people, connecting and empowering others to learn, understand and share stories and skills. Her passion is to ensure the people feel supported and able to incorporate learning, plus, ensuring the patient receives the good quality care through innovation safely.

Some core activities include:

  • Empowering the workforce and embedding the processes with the people
  • Advocating the standards and providing education to all through training, guidance and support 
  • Mentoring Junior CSOs to ensure best practice is implemented, while providing experience and values  
  • Providing organisations with Subject Matter Expertise 

Areas of interest:

  • Remote Patient Monitoring (RPM
  • Shared Care Records (ShCR)
  • Artificial Intelligence  
  • Governance and Assurance Frameworks 
  • Patient intervention and prevention metrics
  • Empowering women in digital health
  •  

Core Values

Passionate
About Safety

Patient 
safety is our
North Star

Transparency
& Honesty

We are committed to building trust with our clients, partners, and colleagues.
We communicate truthfully, and uphold the highest ethical standards in everything we do.

 

Sharing
Expertise

We believe in the power of collective knowledge. We actively share our expertise, learn from one another, and collaborate to elevate the entire healthcare technology ecosystem.

In embracing these core values, we are dedicated to making a positive and lasting impact on the health and care digital health landscape, ultimately improving the quality of services, products through correct compliance.

DEDICATED.

HONEST.

PROFESSIONAL.

DigiSafe Consulting provides a dedicated, honest and professional service, with not only the client but the end user and person at the centre of all we do.

We  firmly believe that true compliance goes beyond checking a box or doing it once, educating the workforce, offering mentoring, guiding, training and support is a big part of what we do, and what we do well. 

Embedding the processes with the people is key!

DIGITAL HEALTH
SPECIALISTS.

We believe sharing knowledge to enable the delivery of good quality care and service is key. We ensure the quality of what we produce is not only compliant with the requirements but understandable, transparent with clear outcomes and recommendations.

Our array of Digital Health Specialists aims to achieve the best results to ensure the assurance of a safe and secure system or product, as well as the deployment and implementation of these. Our goal is to embed the processes with the people to lead to success, not just in theory but within daily practice.

With an understanding of the real-world challenges and local and national strategies for care provision, our team focuses their assessments on the delivery to individuals and end users. From primary, secondary, and social care, along with backgrounds in software and national programs, our team will ensure your product, service, or deployment is safe for use.

We welcome all clients, from small start-ups to large organisations with no, minimal or the most elite in compliance and clinical risk management, we are here to help, guide and shape your journey, together.

Get in touch to see how we can help you.

ASSOCIATES.

Dean Mawson,
Senior Clinical Risk Management Specialist & Auditor

Dean has spent the last 31 years in the healthcare sector as a practicing Clinician and a Health Informatician, for 18 of these, gaining knowledge and experience in clinical practice, management and digital health systems.

Dean started his journey in digital health when he became the clinical lead for a project to deploy an Electronic Patient Record (EPR) into his Trust. Dean then joined a leading digital health supplier and played an important role in the Clinical Risk Management, development, and delivery of a PAS/EPR digital health system focused on the acute setting.

His journey continued becoming an independent Clinical Safety Officer (CSO) supporting the digital health sector suppliers and health organisations with their regulatory compliance. Dean has dedicated some of his time to mentorship, provide advice and guidance and became a Fellow of the Faculty of Clinical Informatics for which, he sit’s on the Clinical Safety Special Interest Group.

Dean also has developed his own Clinical Risk Management training which is CPD accredited by the FCI. This can be offered through DigiSafe Consulting in collaboration with DPM Digital Health.

 

dean mawson

Michael Bell,
DTAC Specialist 

With over 25 years healthcare consulting experience supporting healthtech innovators, NHS Trusts, investors and NHSX, Michael is a veteran in advising and delivering on all aspects of UK, EU and US healthtech compliance, including information security, interoperability, data protection, medical device regulations, DTAC and HIPAA.

Michael is presently working with global healthtech innovators to develop and scale innovative, digital healthtech products and ensure they are compliant with regulations and ready for market, to generate revenues and to improve the health and wellbeing of populations. As an advocate of continuous improvement, Michael has mentored many healthtech start-ups, helping them create a culture of compliance and quality, so that they can bring compliance in house, and continue to deliver safe and secure products, release to release.

Passionate about the power of creativity, when not helping healthtech companies realise their full potential, Michael can be found writing and composing piano music.

 

michael bell

Dr. Tom Bradshaw (MBChb 2014, BMedSci (Hons) MRCGP)
GP & Clinical Safety Officer

As a GP, practicing within the West and North Yorkshire regions, Tom has a passion for primary care and the role that innovative and emerging digital technologies have in the evolution of healthcare within the UK. He has a wealth of experience within the health and social care sector, spanning sixteen years in both community and hospital practice within the NHS and independent organisations, and is all too familiar with the complexity of the issues facing clinical practice.

As an accredited Clinical Safety Officer, Tom recognises the challenges that the DCB 0129 and 0160 regulations present. With his extensive clinical experience, he has an in-depth understanding of the risk management requirements of the NHS and the evolving needs of the health and social care sector as a whole. 

He is passionate about improving patient experiences and outcomes whilst keeping patient safety at the forefront of developmental processes. Tom’s holistic and compassionate approach to patient care is mirrored in his care for his clients, where he thrives on nurturing quality and meaningful relationships throughout the DCB regulatory journey and beyond.

Tom plays an active role in the dynamic Leeds Digital Health Community and the Faculty of Clinical Informatics, alongside being a certified Member of the Royal College of General Practitioners and graduate of the NHS leadership program.

 

tom bradshaw

Dr Ben Littlewood-Hillsdon M.D.
Digital Health & Regulatory Expert

Originally qualifying and practicing in the USA as an orthopaedic trauma specialist Ben returned to the UK just as Digital Health Tech was emerging.

His first role was Chief Clinical Content Officer and he moved through a number of vital roles before ending up as Managing Director but most importantly, he retained the function of EU Person Responsible for Regulatory Compliance (PRRC) / UK Responsible Person.

Having a very clear knowledge of the entire product build and deployment cycle has helped Ben support several organisations with their PRRC needs over the past few years, particularly since Covid-19.

As a seasoned C suite leader Ben can define and deliver robust Healthtech strategies within the realities of tight margins and market pressures.

Ben still retains and maintains his surgical registration and so is also able to deliver a executive medical director resource into healthcare providers, which perfectly complements the demands of PRRC accountability. 

Ben has managed organisations that are commercially dependent on achieving and maintaining ISO 27001, Cyber Essentials +, ISO 13485, DCB 0129 & 0160, DTAC, Class I & II devices, US FDA, HIPAA.

He has implemented the open culture and organisation-wide strategy that enables all to deliver to a high quality with great expected outcomes.

 

dr ben littlewood

Suzanne Ash,
Strategic Operations and Compliance Specialist 

After completing her Public Health Degree in Melbourne, Australia, Suzanne has worked in healthcare for over 25 years, within the NHS, private, insured & third sector in the UK and beyond.

Previously the Managing Director of the largest independent provider of Sexual & Reproductive Health Services to the NHS, Suzanne is a Specialist in Women’s Health. Working in partnership with Global Pharma for the past 3 years, developing a product portfolio to extend their reach and improve patient experience, including the emerging opportunities for digital solutions in this therapeutic area. 

As an Operations & Compliance Specialist, Suzanne is an experienced CQC Registered Manager & Transformation Lead, qualified DPO, designing and implementing compliant Information Security Management Systems for ISO27001, Cyber Essentials and DSP Toolkit , DTAC and Digital Care Services Catalogue. As Medical Device Programme Lead she delivered her client’s ambition to become the first Primary Care Digital Triage product to achieve full compliance with DFOCVC Framework.

As an ISO13485 Lead Auditor, and Medical Device Regulation Specialist in the UK, EU and USA, she led the quality, compliance and safe implementation of a primary care digital triage product for over 10m NHS patients. 

In a recent role as Group Compliance Director for the largest European Telehealth Provider, Suzanne designed and implemented an integrated corporate and product quality and compliance framework, embedding the value of good governance, a framework to be brave, to take informed risk-based decisions.

Through her work with clients, her passion is building a culture where people can make meaningful contributions, provide constructive challenge and offer well-thought through short-term and long-term solutions and ideas for product and service development. 

Her other passion is cars, for which she blames her beloved father.

 

suzanne ash

Dr Jason Broch (MB ChB, BSc (hons), FFCI),
GP, Clinical Advisor & CSO

Jason has a strong history in board-level and strategic leadership. He believes that the true strength of an organisation is defined by its engagement and involvement with staff and stakeholders. He enjoys relationship building in system leadership and has a strong track record in supporting teams and offering clinical leadership in key areas such as Urgent Care, Healthcare IT, Primary Care, cross-organisation transformation, public sector – private sector collaborations and integration.

Jason has led the development and implementation of an Informatics Strategy, delivering an Integrated Health & Care Record and Integrated Business Intelligence. He also supported other transformation work streams providing experience of business capability modelling, improved business intelligence and applying systems thinking around patient-flow. Over recent years, Jason has developed a specific interest in Population Health Management, including the shape of new commercial models and emerging business requirements.

Jason is driven to achieve the best possible outcomes for patients and citizens. Whilst being passionate about success and setting achievable, measurable goals. He has experience in Quality Improvement methods supporting process change and digital safety. Jason has a robust understanding about the Healthcare industry, primarily the NHS in England, but also the common themes affecting international Healthcare and its wider supply chain. As a champion of innovation, he is keen to see new innovations thrive as new commercial opportunities in the sector develop.

Jason has supported companies to develop their Value Proposition and understand where their products are best placed in the Healthcare market. Jason has advised start-ups, SME’s and Large Enterprise; acting as an intelligent customer to help design, place and present innovations.

 

jason broch

Jo Stanton,
Digital Clinical Safety Officer (NMC)

Meet Jo Stanton, a compassionate and highly qualified Children’s Nurse, holding a Bachelor of Science in Children’s Nursing with Honours (BSc Hons) and a Specialist Community Public Health Nurse with a Postgraduate Diploma (PGDIP).

Jo’s career in community healthcare led her to excel as a School Nurse, managing healthcare professionals and implementing immunisation programmes and National Government health initiatives. Her expertise extends to neonatal care, specialising in premature babies from 26 weeks gestation.

Dedicated to excellence, Jo completed Clinical Safety training with NHS Digital, focusing on implementing and maintaining standards outlined in DCB0129 and DCB0160. This commitment extends to crafting a secure digital patient journey, aligning with her dedication to maintaining the highest standards of care.

With extensive experience in NHS trusts, both Acute and Community services, Jo brings a wealth of knowledge and understanding to healthcare delivery. Her adaptability and comprehensive approach to patient care are enriched by diverse exposure.
Jo recently played a crucial role in overseeing Clinical safety processes for go-lives, managing documentation, facilitating workshops, and providing training. Her experience in as-is and to-be workflows, gap analyses, and collaboration with software teams reflects her commitment to digital safety.

In addition to clinical, leadership, and digital safety roles, Jo actively pursues professional development through leadership courses, safeguarding modules, and restorative supervision. This versatile skill set equips her to navigate healthcare leadership intricacies, contributing to a culture of safety and excellence within multidisciplinary teams.

As a healthcare professional experienced in community health, school nursing, neonatal care, and diverse NHS trusts, Jo is dedicated to advancing patient well-being through compassionate care and innovative digital solutions

jo stanton

FIND OUT MORE.

Our associates have years of experience In varied health, care and software environments, with in-depth knowledge ready to share, guide and lead you through your journey. 

We are here to support you with infinite amount of best practices and requirement advice which ensures compliance and assurance.