Our Approach
Combining machine learning and clinical innovation
Our team of clinicians, data scientists and software engineers are bringing cutting edge technology into clinical practice to transform the detection and management of disease.
// HOW IT WORKS
Machine learning & the potential of clinical unstructured data
We develop AI models to recognise patterns in large datasets, process that data and extract meaningful information which can be translated into integrated clinical recommendations. We use natural language processing to analyse healthcare data in the form of written text which allows us to unlock the wealth of information kept as unstructured data within electronic health records.
// COMPLIANCE
Secure, ethical and patient centred
Data security, regulatory compliance and quality assurance are the cornerstones of our approach. Abtrace is committed to transparency and external validation.
Timeline
Abtrace Incorporated
Funding secured
€2 million investment from EIT Health.
ICO Registration
The Information Commissioner’s Office (ICO) is the UK’s independent body that has been set up to uphold information rights in the public interest, promoting openness by public bodies and data privacy for individuals.
Under the Data Protection Act 2018, organisations processing personal data must register on the Data Protection Register. Abtrace is registered under the reference number ZA517064.
GDPR Compliant
The General Data Protection Regulation alongside the Data Protection Act 2018 require organisations to store and process data in accordance with the rights, obligations and principles of autonomy, transparency and confidentiality. Scheduled data protection impact assessments (DPIAs) identify risks, mitigations and responsibilities to ensure that the minimum amount of data is held for clearly defined purposes.
NHS Data Security and Protection Toolkit
All organisations that access NHS patient data must use this tool to provide assurance that they are practising good data security and that personal information is handled correctly.
This allows organisations to measure their performance against the National Data Guardian’s data security standards.
Cyber Essentials Certification
Cyber Essentials is a government-backed, industry-supported scheme to help organisations protect themselves against common online threats. The government requires all suppliers bidding for contracts involving the handling of certain sensitive and personal information to be certified against the Cyber Essentials scheme.
Abtrace has been certified by IASME as meeting the required standards for software and systems to protect against cyber threats.
ISO27001:2013 Certification
This international standards certification requires a two stage on-site initial audit with ongoing surveillance assessments by Lloyd’s Register to assess the Information Security Management System (ISMS) for the management and delivery of software solutions and supporting data infrastructure.
Data Infrastructure penetration tested
Conducted by a CREST approved provider, this test asked an independent group of experts to attempt to breach our data infrastructure in an attempt to discover unknown high-risk vulnerabilities. No such issues were identified.
ISO13485:2016 Certification
This international standards certification requires a quality management system (QMS) where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
This required a two stage on-site audit with ongoing surveillance covering the life-cycle, including design and development, production, distribution, installation, and servicing of an AI based medical device and provision of associated activities.
HSCN Network
Abtrace is connected to the HSCN, a private network for healthcare and social care data. Patient data is transmitted to Abtrace over the HSCN.
UKCA | CE mark achieved
The UKCA and CE mark for a Software as a Medical Device (SaMD) confirms that the product undergoes verification and validation testing, risks are evaluated and mitigated, and that clinical evidence is collected. There is also an ongoing process for post marketing surveillance and quality assurance. This confirms that our clinical decision support software meets the standards for safety and performance for medical devices in the UK and EU, enabling its commercialisation in these markets.
Our Approach
Combining machine learning and clinical innovation
Our team of clinicians, data scientists and software engineers are bringing cutting edge technology into clinical practice to transform the detection and management of disease.
// HOW IT WORKS
Machine learning & the potential of clinical unstructured data
We develop AI models to recognise patterns in large datasets, process that data and extract meaningful information which can be translated into integrated clinical recommendations. We use natural language processing to analyse healthcare data in the form of written text which allows us to unlock the wealth of information kept as unstructured data within electronic health records.
// COMPLIANCE
Secure, ethical and patient centred
Data security, regulatory compliance and quality assurance are the cornerstones of our approach. Abtrace is committed to transparency and external validation.
Timeline
Abtrace Incorporated
Funding secured
€2 million investment from EIT Health.
ICO Registration
The Information Commissioner’s Office (ICO) is the UK’s independent body that has been set up to uphold information rights in the public interest, promoting openness by public bodies and data privacy for individuals.
Under the Data Protection Act 2018, organisations processing personal data must register on the Data Protection Register. Abtrace is registered under the reference number ZA517064.
GDPR Compliant
The General Data Protection Regulation alongside the Data Protection Act 2018 require organisations to store and process data in accordance with the rights, obligations and principles of autonomy, transparency and confidentiality. Scheduled data protection impact assessments (DPIAs) identify risks, mitigations and responsibilities to ensure that the minimum amount of data is held for clearly defined purposes.
NHS Data Security and Protection Toolkit
All organisations that access NHS patient data must use this tool to provide assurance that they are practising good data security and that personal information is handled correctly.
This allows organisations to measure their performance against the National Data Guardian’s data security standards.
Cyber Essentials Certification
Cyber Essentials is a government-backed, industry-supported scheme to help organisations protect themselves against common online threats. The government requires all suppliers bidding for contracts involving the handling of certain sensitive and personal information to be certified against the Cyber Essentials scheme.
Abtrace has been certified by IASME as meeting the required standards for software and systems to protect against cyber threats.
ISO27001:2013 Certification
This international standards certification requires a two stage on-site initial audit with ongoing surveillance assessments by Lloyd’s Register to assess the Information Security Management System (ISMS) for the management and delivery of software solutions and supporting data infrastructure.
Data Infrastructure penetration tested
Conducted by a CREST approved provider, this test asked an independent group of experts to attempt to breach our data infrastructure in an attempt to discover unknown high-risk vulnerabilities. No such issues were identified.
ISO13485:2016 Certification
This international standards certification requires a quality management system (QMS) where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
This required a two stage on-site audit with ongoing surveillance covering the life-cycle, including design and development, production, distribution, installation, and servicing of an AI based medical device and provision of associated activities.
HSCN Network
Abtrace is connected to the HSCN, a private network for healthcare and social care data. Patient data is transmitted to Abtrace over the HSCN.
UKCA | CE mark achieved
The UKCA and CE mark for a Software as a Medical Device (SaMD) confirms that the product undergoes verification and validation testing, risks are evaluated and mitigated, and that clinical evidence is collected. There is also an ongoing process for post marketing surveillance and quality assurance. This confirms that our clinical decision support software meets the standards for safety and performance for medical devices in the UK and EU, enabling its commercialisation in these markets.
