Identification of issues
Legal issue 1
The NHS application handle sensitive biometric data and often function as medical devices. If
the app isn’t built to strict legal standards, it creates a massive liability. Using personal phones to
access data or adding features that “analyse” health without medical license/certification. The risk is
heavy government fines and lawsuits if the data is leaked, and the potential of the app to be legally
shut down by health regulators. The Mitigation is to use encryption, to ensure no data is saved on
the phone itself and strictly define the app as an information tool.
Legal issue 2
The second legal issue is Professional Negligence and Clinical Liability. This issue focuses on
patient harm caused by reliance on the application. The issue arises when a mobile app provides a
data visualization or a summary that leads a clinician to miss a diagnosis or prescribe the wrong
treatment. If the app is found to be the source of the error, the developer and the healthcare
provider face a complex legal battle over who is responsible for the faulty decision. The Mitigation is
to always use time-stamped data, always show exactly when apiece of data was last updated so the
clinician knows if they are looking at real-time or stale info.
Usability issue 1
Clinicians often need to make split decisions based on complex datasets. When the data is
squeezed onto a small mobile screen, it becomes hard to read. If a clinician can’t find critical data
because it’s buried in a submenu, it leads to patient harm. The Mitigation is to use a summary
dashboard that highlights only the most critical values in red, hiding other values in the main menu.
Usability issue 2
The second usability issue is the lack of seamless context. In a fast-paced hospital, a clinician
is constantly interrupted. If it is difficult for the app to switch between tasks quickly, it causes
context loss. The clinician loses their train of thought, leading to errors or frustration. If a doctor has
to navigate back through five screens to find where they left off, it adds 30-60 seconds to every
patient interaction. The Mitigation is to provide a persistent patient tab at the top of the screen that
allows the clinician to jump between views without losing the current patient context.
Risk Register
1. Data Security: Risk of unauthorised access. Sensitive patient health information is accessed
by unauthorized users due to weak credentials. The Mitigation strategy is to implement
Multi-Factor Authentication (MFA), end-to-end encryption for data in transit and automatic
session timeouts.
2. Scheduling: Underestimating the time required for medical device certification pushes the
launch date back. The Mitigation strategy is to build a 3-month buffer into the timeline
specifically for a regulatory audit and hiring a clinical safety officer.
3. Communication: Developers and clinicians have different views on essential features,
leading to a product that doesn’t fit the clinical workflow. The Mitigation is to establish
weekly clinical review boards where active doctors test prototypes and provide immediate
feedback on usability.
4. Data Security: Insecure mobile hardware. Clinicians use personal, unmanaged phones that
may be lost, stolen or infected by malware, exposing the portal. The mitigation is to use a