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 no matter they environment, 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, a dynamic leader and seasoned consultant, heads up DigiSafe as the Clinical Director with a wealth of experience and expertise in clinical safety, digital health transformation, and programme management. Her journey in healthcare and consultancy spans over a two decades, marked by pivotal roles in ensuring compliance with mandated clinical safety standards and overall organisational governance.
Rebecca’s core competencies encompass in-depth knowledge of the clinical safety standards and related international ISO standards and other regulatory frameworks.
With a focus on strategic approaches and processes, she ensures organisational excellence while empowering the workforce and leading change, the right way. Her experiences include been the clinical safety lead for the Yorkshire and Humber Shared Care record programme, here she developed the core assurance models and frameworks across multiple integrated care boards. Rebecca worked at NHS Digital, as a Senior Pharmacy Technician and a Clinical Informatic for a multitude of national programmes.
Some core activities include:
Areas of interest:
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.
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.
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.
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.
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.
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
Sharon Fisher,
Project Manager
Over 15 year’s experience of working within the National Health Service, across NHS Digital and NHS England, being part of programmes such as Electronic Prescription Service and GP Connect in a Project Management role.
I have experience in ensuring projects are smoothly transitioned into operation, with my strengths being project planning and stakeholder communication.
Previous roles within the NHS have included Project Support and PMO Analyst, providing programme and project support for delivery and development. Previous projects have included organising the delivery of 800 pharmacy training events, and capturing and complying case studies, both of which roles were national across the country.
I have a wide variety of experience and skills sets; Risk Management, Stakeholder Management, PMO Service, Information Management, Analytical Thinking, Quality Assurance and Standard, and Initiative.
I’m a highly motivated individual who enjoys a new challenge, working individually and as part of a fast moving team. I have a proactive approach and possess drive and ambition to produce the highest standard.
Outside of work, I enjoy walking and hiking in the great outdoors. I enjoy most fitness related activities.
Steve Roche,
Occupational Therapist
Steve is a registered Occupational Therapist with more than 15 years clinical experience and an accredited Clinical Safety Officer and digital health leader with a passion for digital transformation, clinical safety, and quality improvement. Prior to his healthcare career, Steve specialised in quality assurance and continuous improvement methodologies in the automotive industry.
As a Clinical Safety Officer, Steve utilises the transformative power that digital Clinical Safety can have to ensure Health IT systems and processes are effective, safe, and efficient. Steve has worked and led on numerous digital clinical safety deployment projects at Trust, ICB, ICS, regional, and national level.
These skills and a desire to improve the quality of care, outcomes and experiences for people, their families, and carers is what motivates Steve professionally.
Antoni (Toni) Olewicz
Toni is a registered pharmacist with the General Pharmaceutical Council (GPhC) and holds accreditation as a Clinical Safety Officer. His professional background includes extensive experience in community pharmacy and several years in the IT sector focusing on pharmacy computer systems, with one of the primary suppliers in the UK.
During his tenure, Toni navigated the transition to the DCB0129/0160 standards, which became mandatory for healthcare computer systems, notably impacting the Electronic Transfer of Prescription Project, through the different phases into how we know it today. He played a pivotal role in the design, planning, and implementation of the Dictionary of Medicines and Devices within the flagship software product's database, ensuring meticulous data mapping.
To boost capacity and reliability for Electronic Prescription Handling, Toni served as the Clinical Safety Officer for a significant middleware project, overseeing the safety aspects of a robust and secure messaging system for electronic prescription data transfer. His responsibilities extended to providing assurance for vaccination portals and Optometry systems.
In his capacity as a Clinical Safety Manager for a prominent Medical Ophthalmology systems supplier, Toni provided essential CSO support for legacy products, documentation support for DCB0129 and updated Technical Files for Medical Device Registration, and Clinical Incident Management.
DigiSafe 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!
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.
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.
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.
