Digital Clinical Safety Management
Investing in digital clinical risk management is an opportunity to enhance patient safety and streamline healthcare operations. It ensures adherence to standards and guidelines, enhancing organisational reputation.
Common problems we unravel
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“Our digital product handles sensitive and clinically-critical data. We want to find out how we might minimise and mitigate any digital clinical risks our product design might bring. ”
“Our health organisation is planning on implementing a SaaS product which will have significant impact on our business and clinical practice. We need help mitigating both business and clinical risks while we are implementing this and a plan to maximise the use of the new platform.”
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“There is a clinical data requirement we need to meet but we don’t know how we can gather this information from our existing business and clinical practice. We want to gather this information as we go so we don’t have to spend a lot of time and money on regular audits.”
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"Our organisation really needs to be able to solve ongoing problems as we develop our product/s but we also want to be able to that in-house. We just don't have the skill sets right now."
What is Digital Clinical Safety?
Digital clinical safety involves processes to ensure digital health technologies operate effectively and securely in clinical environments. It includes assessing, monitoring, and managing risks linked to tools like electronic health records and telemedicine. The goal is to safeguard patient data, uphold medical decision integrity, and enhance health outcomes through standards that reduce technology-related hazards. This field is vital as healthcare evolves with new technologies, prioritising patient safety in the digital era.
When do I need this service?
In an increasingly complex digital landscape, prioritising 'digital clinical safety' in your products is essential. This concept ensures that digital health solutions not only comply with regulatory standards but also protect patients from potential harm. With the rise of connected devices and telehealth, integrating robust safety measures into your products safeguards user data, enhances trust, and improves overall outcomes. By adopting digital clinical safety, you not only fulfill ethical and legal responsibilities but also differentiate your offerings in a competitive market, fostering loyalty and enhancing your brand's reputation. Prioritise safety for the well-being of your customers and the credibility of your solutions.
What are the benefits?
Prioritising digital clinical safety helps identify and mitigate risks, safeguarding patients and ensuring regulatory compliance, which can lower the chances of recalls or legal issues. This commitment fosters a culture of quality and accountability, enhancing your product's reputation as a trusted choice for healthcare providers and patients. It can improve marketability, customer loyalty, and provide a competitive advantage. Investing in digital clinical safety encourages innovation by integrating safety into early product development, streamlining processes and enhancing usability for effective and safe solutions. Long-term benefits include improved patient care, reduced liability, and a stronger brand. Embrace digital clinical safety as a strategic advantage for superior healthcare solutions. Prioritise safety today for the benefit of your patients and business.
Outputs you can expect
Digital Clinical Safety Plan
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Item description
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Item description
Risk Managment
Incident Managment
How we unravel
Governance
We like to start by having an understanding of forming a governance structure. This provides transparency of an organisation’s responsibilities over the products it manufactures and/or implements.
Risk Management
Risk management refers to a proactive attitude and process regarding risks for the lifecycle of a digital health product or system. This includes personnel, process and culture of managing risks proactively.
Stakeholder management
Stakeholder management may include vendor management as well as co-design partner management which could include the end users both consumers and the health workforce. This stakeholder management process requires standards for conformance and processes to be in place to better manage these relationships.
Incident Management
Incident management refers to identifying and managing clinical adverse events or near misses caused by digital health products or systems. An incident management process is to ensure there is a consistent method for responding to incidents that have or may influence clinical safety.