According to a Journal of Clinical and Translational Science study ‘Software to manage regulatory workflows for medical device development at academic medical centers: A critical gap’, “Medical device development is a complex and highly regulated process that can take 3–10 years and $31–94 M of investment to reach commercialization.”
Healthcare organizations must understand the concept of software sunsetting because it directly impacts patient safety, data integrity, compliance, and operational efficiency in an environment where technology is deeply integrated into care delivery. Healthcare technology platforms handle sensitive patient data and operate under strict regulatory frameworks, making the management of software lifecycles necessary to avoid failures that could jeopardize care quality and privacy.
Software sunsetting is the planned retirement of outdated or unsupported software. It ensures that healthcare systems do not rely on obsolete platforms vulnerable to security breaches or incompatible with current standards. Without a clear understanding of sunsetting, organizations risk data loss or corruption during transitions, which can disrupt clinical workflows and compromise patient outcomes.
The complexity of healthcare information systems, such as electronic health records (EHRs) and intensive care databases, requires careful planning to maintain data accessibility and interoperability when phasing out software. Journal of the American Medical Informatics Association research also shows that while health information technologies (HIT) can improve care processes, they often increase documentation time and require adaptation; thus, sunsetting legacy systems without proper strategy can exacerbate inefficiencies and staff burden.
A collaborative study, ‘Ending the Life of a Software Product’ notes that, “We define sunsetting as the process of planning and executing the end-of-life of a software product that is currently in use by customers and maintained by a software producing organization. The end-of-life of a software product describes the point after which the product is no longer maintained or supported by the manufacturer of the software product. Phase-out is an alternative term for sunsetting. Sunsetting is actually part of the portfolio management process.”
Software sunsetting refers to the deliberate process of retiring or phasing out software applications that have become outdated, unsupported, or no longer fit for purpose within healthcare environments. Sunsetting happens primarily because legacy healthcare software often creates risks, including security vulnerabilities, incompatibility with current technological standards, and inability to comply with evolving regulatory requirements.
Many healthcare organizations continue to rely on legacy systems running on unsupported operating systems, which increases exposure to cyber threats and operational failures. The sunsetting process is necessary to avoid these risks by replacing or decommissioning such systems in a controlled manner to ensure continuity of care and data integrity. Furthermore, healthcare software may be sunsetted due to advances in technology that offer improved functionality, interoperability, and user experience, which legacy systems cannot provide.
Healthcare software medical devices, and clinical decision support systems, are often vulnerable to security breaches caused by outdated or unsupported software, poor credential management, and hard-coded passwords, which can directly threaten patient well-being and safety.
The stakes are heightened because malfunctioning or insecure software can lead to clinical errors, disrupt patient care, and even cause life-threatening incidents, as documented in historical cases like the Therac-25 radiation therapy accidents. Healthcare software must comply with stringent regulatory frameworks such as HIPAA, requiring continuous protection of sensitive patient data during any software transition, including sunsetting.
The complexity of healthcare workflows means that software changes can increase cognitive load on clinicians, cause communication breakdowns, and necessitate workarounds that may compromise care quality. Interoperability challenges during sunsetting can hinder seamless data exchange, affecting coordinated care and clinical decision-making.
Legacy healthcare software often contains vulnerabilities such as poor credential management, hard-coded passwords, and buffer overflows, which can be exploited if the software is not properly retired or updated, leading to unauthorized access, data corruption, or system failures that directly endanger patients.
A conference paper from the International Conference of Software Engineering 2025 conference states, “Those abandoned packages expose many dependents, but average direct exposure even for widely used packages is lower than might be expected, suggesting that collaborative responsible sunsetting strategies might be feasible. Developers seem to care about abandonment – 18% of exposed projects remove the abandoned dependency, which is roughly comparable with other dependency management practices such as installing updates.”
For example, malfunctioning medical devices or erratic behavior in software controlling medication delivery can cause life-threatening incidents. Inadequate planning during sunsetting can result in data loss, compromised interoperability, and workflow interruptions, which hinder clinical decision-making and continuity of care.
Software that qualifies as Software as a Medical Device (SaMD) in the United States is regulated by the FDA through pathways such as the de novo and 510(k) processes, which require demonstration of safety and effectiveness or substantial equivalence to predicate devices. According to the NPJ Digital Medicine study ‘Regulatory considerations to keep pace with innovation in digital health products’, “Digital tools that meet the definition of a SaMD, but are considered to pose only a low risk to patients, qualify for enforcement discretion and can be made available without active FDA oversight.” These regulatory frameworks are designed to address risks associated with medical software throughout its lifecycle, including when it is being phased out or sunsetted.
The FDA’s emerging Digital Health Software Precertification (Pre-Cert) Pilot Program aims to provide a more responsive regulatory approach by focusing on developer excellence and real-world performance, which is needed for managing software transitions safely. Additionally, regulations mandate strict protections for patient data privacy and security, aligning with laws such as HIPAA, which remain applicable during software retirement to ensure continued safeguarding of sensitive health information.
Related: HIPAA Compliant Email: The Definitive Guide (2025 Update)
Healthcare organizations use a variety of software including appointment scheduling, medical billing, hospital management, medical equipment management, and clinical decision support systems.
Transitions like migrating from one EHR system to another or upgrading software introduce safety risks that can affect patient care, data integrity, and workflow continuity.
Challenges include developing risk assessment tools, standardizing user interfaces to reduce errors, ensuring safety in networked clinical environments, and managing IT system transitions safely.