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  1. Proceedings of the 4th International Workshop on Software Engineering in Health Care (SEHC '12)
  2. Requirements specification for apps in medical application platforms
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A timed model for healthcare workflows based on CSP
A case study in interoperable support for collaborative community healthcare
What is a care pathway?
Cancer treatment planning: formal methods to the rescue
Requirements specification for apps in medical application platforms
Variabilities as first-class elements in product line architectures of homecare systems
Certification and regulatory challenges in medical device software development
Introducing safety cases for health IT
Engineering the healthcare collaboration space
Creating healthcare training simulations in virtual worlds
A multi-touch approach to control MRI scans: a user-centered study report
From a traditional behavioral management program to an m-health app: lessons learned in developing m-health apps for existing health care programs

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Requirements specification for apps in medical application platforms

Content Provider ACM Digital Library
Author Hatcliff, John Procter, Sam Larson, Brian Chalin, Patrice
Abstract Existing regulatory agency guidance documents and process standards for medical devices (i.e., IEC 62304) generally consider medical devices to be stand-alone monolithic systems. The format and content of a system requirements document largely follows that of conventional embedded safety-critical systems. However, a vision is emerging of a new paradigm of medical system based on the notion of a medical application platform (MAP). A MAP is a safety- and security-critical real-time computing platform for (a) integrating heterogeneous devices, medical IT systems, and information displays via a communication infrastructure and (b) hosting application programs (i.e., apps) that provide medical utility via the ability to both acquire information from and update/control integrated devices, IT systems, and displays. To ensure a regulatory pathway for MAPs, it is necessary to adapt traditional development processes and artifacts to the specific characteristics of MAP architectures and constituent components. In this paper, we provide an initial proposal for developing and formatting requirements for MAP apps. For illustration, we consider an app that implements two "smart alarms" for pulse oximetry monitoring in a clinical context.
Starting Page 26
Ending Page 32
Page Count 7
File Format PDF
ISBN 9781467318433
Language English
Publisher Association for Computing Machinery (ACM)
Publisher Date 2012-06-04
Access Restriction Subscribed
Subject Keyword Medical information systems Requirements specification Biomedical communication Biomedical monitoring
Content Type Text
Resource Type Article
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