Ultraprep® programs are hosted in “the cloud”, which allows patients to truly own their data and share it with a particular organisation when they choose to. This is an innovative approach and it is therefore essential that particular attention is paid to Information Governance, and that the Caldicott Guardian of a healthcare providing organisation signs to accept the arrangements prior to implementation.
The software is hosted on Microsoft Azure Servers which are certified to hold Patient Identification Data (PID) and for use by NHS Trusts and other public and government bodies. A review of the decision to host Ultraprep® programs in the cloud, done by the Clinical Safety Officer, concluded that “Microsoft Azure Servers are an excellent choice for the storage of PID for Ultramed®”.
The Ultramed® IG Process
Passwords are both hashed (mathematically jumbled) and salted (jumbled with additional random characters) as part of the default behaviour in ASP. net Identity, which is the framework used for authentication.
Ultramed is legally responsible for the Information Governance and the transfer of a person’s PID to a healthcare providing organisation. This is done through a secure File Transfer Protocol (FTP) process or by using encrypted email. The responsibility to provide a suitable secure address for the patient’s information to be sent to rests with the receiving healthcare-providing organisation.
Once the data is received on a healthcare provider’s secure server within the N3 firewall (for NHS organisations), then that organisation is responsible for the data in the usual way.
A deliberate decision was taken in the development of the Ultraprep programs to have the software hosted outside the NHS N3 firewall. This means that a patient can own their account and their data and share it with Any Qualified Provider (AQP) who is going to care for them. Microsoft Azure Servers are certified to hold PID and for use by NHS Trusts and other public and government bodies.
For data in transit, Azure uses industry-standard transport protocols between user devices and Microsoft data centres, and within data centres themselves using Transport Layer Security (TLS).
For data at rest, Microsoft Azure Servers offer a wide range of network security and threat detection strategies in addition to AES-256 encryption.
United Kingdom G-Cloud OFFICIAL Accreditation
Azure has received OFFICIAL accreditation from the UK Government Pan Government Accreditor. Azure is available on the G-cloud Framework, and details can be found on the UK’s Digital Marketplace. The OFFICIAL rating benefits a broad range of UK Public Sector organisations, including Local and Regional Government, National Health Service (NHS) trusts and some central government bodies which hold or transact public sector data for business conducted at the OFFICIAL level of Security Classification. Details of the OFFICIAL accreditation can be found in the references section of this document and form part of the UK Government’s Cloud Security Principles. OFFICIAL accreditation covers the Azure in-scope services listed on the Azure Trust Centre.
A standardised information security management system that is implemented by a wide range of public and private bodies to provide structure, and demonstrate evidence of a multifaceted approach to information security and Information Governance.
ISO27018 is the cloud-based equivalent of ISO27001/27002. Microsoft Azure Servers are currently the only cloud-based server to have this accreditation.
Backup and Retention of Records
Patient records will be maintained for as long as legally required under the “retention” regulations. Currently for hospital records this is for a minimum of 8 years after the conclusion of treatment or death. Department of Health’s records of retention schedule - Part 2 (Second Edition) Annex D1. If regulations were to change, Ultramed would follow new regulations.
If there was a request from a patient to delete their record, Ultramed would follow the ICO guidance but also seek legal advice to ensure that our proposed action was appropriate. It would be the intention to do as a patient requested provided it was legally sound and consistent with the ICO guidance.
ISB0129 - Clinical Risk Management: its Application in the Manufacture of Health IT Systems
The creation and implementation of ever more powerful software solutions for use in healthcare environments provides the potential for enormous benefits for patients and healthcare professionals alike. However, there is also the potential for the introduction of risk, which could affect patients, healthcare providers, health technology providers or combinations of the above. For this reason, potential risks associated with the development and deployment of software for use in healthcare must undergo a stringent process of risk assessment and management.
Ultraprep, like all of Ultramed’s products is built from the ground upwards with patient safety and security in mind. To demonstrate our commitment to ensuring patients and their information are appropriately protected, Ultramed® has enrolled on the ISB0129 accreditation process.
ISB0129 is a standard defined by the Health and Social Care Information Centre. The purpose of the standard is “to ensure that effective clinical risk management is carried out by organisations that are responsible for developing and modifying Health IT Systems”.
All documentation relating to the Ultraprep ISB0129 accreditation is stored in the Clinical Risk Management File on Ultramed’s servers. This suite of documents and processes is continually evolving and improving, and undergoes regular review. The main areas of focus for Ultramed to achieve ISB0129 accreditation are listed below. It should be noted that this list is provided as a general overview and is by no means a comprehensive examination of the ISB0129 system and methods.
- Reviewed and assigned appropriate resources to completing a robust risk assessment.
- Assigned a Clinical Safety Officer, who reports directly to Ultramed’s directors
- Produced a clinical risk management plan (a plan that documents how Ultramed will conduct clinical risk management)
- Continually amends the clinical safety case. (An accumulation and organisation of product and business process documentation and supporting evidence, through the lifecycle of Ultraprep)
- Produced a clinical safety case report. (A report that presents the arguments and supporting evidence that provides a compelling, comprehensive and valid case that Ultraprep is a safe application)
- Continually updates and reviews the Ultraprep Hazard Log. (A mechanism for recording and communicating the on-going identification and resolution of hazards associated with Ultraprep. This will include risk assessment in terms of; severity, likelihood and implications.)
- Continually updates and reviews the Ultraprep safety incident management log. (A mechanism for recording and communicating any incidents arising from the development, deployment and use of Ultraprep)