Software of unknown provenance

The term was originally mostly used in relation to works of art but is now used in similar senses in a wide range of fields, including archaeology, paleontology, archives, manuscripts, printed books and science and computing. This suggests a restricted distribution of such vessels, even though the many specimens with an unknown provenance argue for caution in this respect. So to avoid the evil of ambiguity and to avoid confusion, i just call it all software. Software of unknown provenance soup, is formally defined within iec 62304 medical device software software life cycle processes, but generally understood as off the shelf software items which are used in a medical device we will discuss the formal definition in a future blog.

P resented by george romanski, verocel, in conjunction with mentor graphics embedded software. In building software for medical devices it seems fairly common to have certain proprietary software tools that somehow contribute either code or data to be incorporated into the medical device software that is being built. How to select ots software based on software engineering principles and common sense. Its my understanding and thats not to say its right that, irrespective of the releases of the standards, if you didnt develop a ui in accordance with the standard and gather the applicable records, you can adopt the standard moving forward, as you modify the ui. Ways to safely handle third party code creeping into medical device development. Solar optical universal polarimeter experiment soup. Using software of unknown provenance in medical device.

Worse, some thoughtless developer has neglected to put version numbers on the jars. Guidance for the content of premarket submissions for software contained in medical devices guidance for industry and fda staff may 2005. The standard spells out a riskbased decision model on when the use of soup is acceptable, and defines testing requirements for soup to support a rationale on why such software should be used. Provenances definition of provenances by the free dictionary. Our products include third party software of unknown provenance soup. Risks caused by offtheshelf software ots or software of unknown provenance soup are often not identified properly. Understanding the fda guideline on offtheshelf software. The history of the ownership of an object, especially when documented or. Regulators of iec 62304 have put a lot of energy into normalizing how to handle soups software of unknown provenance for software of. Software of unknown provenance how is software of unknown. Research into the security of software of unknown provenance soup is also included. The iec 62304 defines a soup as a software component, which is already developed and widely available, and that has not been designed to be integrated into the medical device also known as offtheshelf software, or previously developed software, not available for the adequate records. Learn more eliminate the uncertainty in your software. Understanding uoup user interface of unknown provenance.

Chain of custody is an equivalent term used in law, especially for evidence in criminal or commercial cases. The purposes of this study were to estimate variations of tree height and basal diameter within provenance and among provenances, to compare scots pine to. Otssoup software validation strategies bob on medical. Offtheshelf ots software is commonly being considered for incorporation into medical devices as the use of generalpurpose computer hardware becomes more prevalent. Reused components and embedded apis introduce unplanned workflow and logic. This page is about the meanings of the acronymabbreviationshorthand soup in the computing field in general and in the software terminology in particular. It is very unlikely that you can determine how this software was developed, so its up to you to validate that it does what its supposed to do. The most popular abbreviation for software of unknown provenance is. No regulator calls it firmware of unknown provenance. The fda has been working to change that by requiring a more systematic approach 16 april, 2020.

User interface of unknown provenance uoup applicability. Soup abbreviation stands for software of unknown provenance. Dependable computing proving security properties in software of unknown provenance sound static analysis for security workshop ashlie b. The standard does not stop at the definition though, it also identifies those steps in the development process. Proving security properties in software of unknown provenance. With the growth of shared services and systems, including social media, cloud computing, and serviceoriented architectures, finding tamperproof methods for tracking files is a major challenge. Understanding the new requirements for qms software.

Back to program proving security properties in software of unknown provenance ben hocking dependable computing. Fda guidance on iec 62304 software standard plianced inc. This program can help you determine the provenance of such files. In some instances this may be legacy custom software, but these days it probably means the integration of an open source program or library into. According to iec 62304 terminology, 3rd party software are software of unknown provenance, aka soup. May 17, 20 according to iec 62304 terminology, 3rd party software are software of unknown provenance, aka soup. Soup software of unknown provenance johner institute.

Software item a software component or module a part of a complete software system software unit the smallest software item. Software component that is already developed and widely available, and that has not been developed, to be integrated into the medical device also known as offtheshelf software, or previously developed software for which adequate records of the development process are not available. Soup stands for software of unknown or uncertain pedigree or provenance, and is a term often used in the context of safetycritical and safetyinvolved. Software of unknown pedigree how is software of unknown. To follow up on lei zongs post last week about threat assessments, a specific area of concern that is overlooked is related to vulnerabilities of software of unknown provenance soup items. Developing medical device software to iec 62304 mddi online. Iec 62304 software of unknown provenance soup iec 62304 defines software that is already developed and generally available as software of unknown provenance, or soup. One approach to satisfy two sets of rules as stated in the last blog post, there are two sets of rules for sw regulationtwice the rules, twice the confusion. The works cited here were presented between january and august 2014.

If nothing happens, download github desktop and try again. In the safety and security community, everyone knows that the best time to include formal analysis of your desired properties is at the very beginning. For example, you might have a tool that does certain calculations and generates a set of data tables as output. It is often firmware on a third party device or even windows, and our own embedded code. Hey mum, uoup is the acronym for user interface of unknown provenance. Although i dont have a solid answer to the question. The fda has been working to change that by requiring a more systematic approach. Soup is software that has not been developed with a known software development process or methodology, or which has unknown or no safetyrelated properties. Provenance definition of provenance by the free dictionary. Ben rodes1, john knight1, jack davidson2, and clark coleman2 1dependable computing 2zephyr software. Provenance from the french provenir, to come fromforth is the chronology of the ownership, custody or location of a historical object. Security guideline for the electricity sector supply chain. Soup is an acronym for software of unknown provenance. Software of unknown pedigree aka software of uncertain provenance, aka soup has been a term used primarily in scenarios where softwarehardware.

Content of premarket submissions for software contained in. Our vision is that one day, every great product, whether a bottle of wine or a pair of jeans, will come with provenance. Jun 01, 2010 software of unknown provenance, or soup, is any code tools or source code that does not have formal documentation or was developed by a third party and has no evidence as to the controls on the development process. Our design documents are extensive in number and volume. This is generally available software that has not been developed for the respective medical device. The standard describes such components as soup, software of unknown provenance or offtheshelfsoftware. Ubersetzungen fur software of unknown provenance im englischdeutschworterbuch, mit echten sprachaufnahmen, illustrationen, beugungsformen. Soup is defined as software of unknown provenance frequently. Explore topics that include using software of unknown provenance soup, mitigating risk throughout the life cycle, managing requirements, code quality standards and configuration management. Software of unknown provenance, or soup, is any code tools or source code that does not have formal documentation or was developed by a third party and has no evidence as to the controls on the development process. Overview of software development processes and activities source. My recommendation is to base your software development procedures on the iec 62304 standard, which is. Is your code of unknown provenance threatening to cause unintended access and use of pii and other sensitive information.

Jul 25, 2017 hey mum, uoup is the acronym for user interface of unknown provenance. The term provenance is used when ascertaining the source of goods such as computer hardware to assess if they are genuine or counterfeit. Software of unknown provenance soup, is formally defined within iec. Open source plus all of the above include hidden vulnerabilities all code of unknown provenance threaten to include unintended access and use of pii and other sensitive information. The standard does not stop at the definition though, it also identifies those steps in the. Software of unknown provenance soup formal methods are best when applied at the beginning embedded systems may rely on software with no source code or with source code contributed by unknown authors even when you have source code, compiler can introduce errors new software might use existing libraries of unknown provenance. At the same time however they open up new possibilities for organisations. The fda perspective on human factors in medical device software development 38. Jul 21, 2014 there is another practical reason i call it all software. Legacy and thirdparty code carry forward unknown dependencies. The risk management process, specifically for software systems, needs to be improved. Software of unknown pedigree aka software of uncertain provenance, aka soup has been a term used primarily in scenarios where softwarehardwarefirmware governs a system that if breached or malfunctioning could have explicit implications on consumer safety. Common types of ots software used by medical devices companies.

Medical device usability david adams global head, active medical devices add logo on slide 4. Software provenance encompasses the origin of software and its licensing terms. Provenance meaning in the cambridge english dictionary. Crosscode eliminates entire categories of risk by identifying, mapping and visualizing production dependencies across executable, managed service, database, api, and.

This is particularly true when using complex software components whereby the. Software of unknown pedigree aka software of uncertain provenance, aka soup has been a term used primarily in scenarios where software hardwarefirmware governs a system that if breached or malfunctioning could have explicit implications on consumer safety. Soup stands for software of unknown or uncertain pedigree or provenance, and is a term often used in the context of safetycritical and safetyinvolved systems such as medical software. Fda software guidances and the iec 62304 software standard. This could be due to improper definitions of these types of software or not classifying software into different categories. Equipment and software of unknown or unverified origin code is inserted or altered by adversaries before insertion or use maintenance equipment sent for repair or. This ots offthe shelf training will recommend the approach that should be taken on the use of ots software must be based on software engineering principles and common sense. The iec 62304 standard calls out certain cautions on using software, particularly soup software of unknown pedigree or provenance. What is the abbreviation for software of unknown provenance. How to select ots software based on software engineering principles and common.

Sep 12, 2011 in building software for medical devices it seems fairly common to have certain proprietary software tools that somehow contribute either code or data to be incorporated into the medical device software that is being built. Software developed and maintained with respect to iec 62304 requirements or with respect to medical devices regulations are not soup. Soup is software that is actually incorporated into the medical device e. If you are visiting our nonenglish version and want to see the english version of software of unknown provenance, please scroll down to the bottom and you will see the meaning of software of unknown provenance in english language. Part 1 because every good software starts with soup. May 22, 2018 soup stands for software of unknown or uncertain pedigree or provenance, and is a term often used in the context of safetycritical and safetyinvolved systems such as medical software. Good provenance requires tools and processes for identity management, access, tagging, tracing, and more. Software of unknown provenance an introduction team consulting. All of these fall under the category of soup software of unknown provenance or pedigree. Soup is software that has not been developed with a known software development process or methodology, or which has unknown or no safetyrelated properties often, engineering. This code by definition is deemed to be capable of producing faults.