The Impact of Regulatory Compliance on Agile Software Processes with a Focus on the FDA Guidelines for Medical Device Software

2011 ◽  
Vol 2 (2) ◽  
pp. 67-81 ◽  
Author(s):  
Hossein Mehrfard ◽  
Abdelwahab Hamou-Lhadj
Keyword(s):  
Medical Device ◽  
Software Process ◽  
Regulatory Compliance ◽  
Extreme Programming ◽  
Organizational Processes ◽  
Medical Device Software ◽  
Development Processes ◽  
Agile Software ◽  
The Impact ◽  
Fda Regulations

The difficulty of complying with different regulations has become more evident as a large number of regulated businesses are mandated to follow an ever-increasing set of regulations. These regulations often drive significant changes in the way organizations operate to deliver value to their customers. This paper focuses on the impact of the Food and Drug Administration (FDA) regulations on agile software development processes, which in many ways can be considered as just another type of organizational processes. Particular focus is placed on the ability for Extreme Programming (XP) to support FDA requirements. Findings show that XP fails to meet many of the FDA guidelines for medical device software, which increases the risks of non-compliance for organizations that have adopted XP as their main software process. The results of this study can lead the work towards designing an extension to XP for FDA regulations.

The Impact of Regulatory Compliance on Agile Software Processes with a Focus on the FDA Guidelines for Medical Device Software

2013 ◽  
pp. 298-314
Author(s):  
Hossein Mehrfard ◽  
Abdelwahab Hamou-Lhadj
Keyword(s):  
Medical Device ◽  
Software Process ◽  
Regulatory Compliance ◽  
Extreme Programming ◽  
Organizational Processes ◽  
Medical Device Software ◽  
Development Processes ◽  
Agile Software ◽  
The Impact ◽  
Fda Regulations

The difficulty of complying with different regulations has become more evident as a large number of regulated businesses are mandated to follow an ever-increasing set of regulations. These regulations often drive significant changes in the way organizations operate to deliver value to their customers. This paper focuses on the impact of the Food and Drug Administration (FDA) regulations on agile software development processes, which in many ways can be considered as just another type of organizational processes. Particular focus is placed on the ability for Extreme Programming (XP) to support FDA requirements. Findings show that XP fails to meet many of the FDA guidelines for medical device software, which increases the risks of non-compliance for organizations that have adopted XP as their main software process. The results of this study can lead the work towards designing an extension to XP for FDA regulations.

scholarly journals AGILE SOFTWARE DEVELOPMENT

2021 ◽  
Vol 5 (12) ◽  
Author(s):  
Gopalkrishna Waja ◽  
Jill Shah ◽  
Pankti Nanavati
Keyword(s):  
Software Development ◽  
Agile Software Development ◽  
Extreme Programming ◽  
Software Project ◽  
Research Papers ◽  
Agile Methodology ◽  
Development Methodology ◽  
Software Development Methodology ◽  
Agile Software ◽  
The Impact

Agile Software Development plays a quintessential part in modern day software development. The term Agile refers to frequent reassessment and adaptation of plans and techniques and dividing tasks into shorter tasks for efficiency. Agile Software Development differs considerably from Traditional Software Development Methodology. Agile methodology aims to deliver features of a software project in small steps within a short duration of time (i.e., iterations). Hence, it becomes necessary to use agile software development methodology in todays’ fast-paced revolutionizing software industry. This paper discusses the important subtopics of Agile Software Development which gathered by reviewing/surveying of research papers. First, is the Agile Planning Life Cycle which consists of various stages such as pre-planning, planning, release planning and product backlog management. In the next section, principles such as Scrum, Extreme Programming, Kanban and Lean are discussed. The last section comprises the impact of Agile principles on software quality.

A Review of Design for X Methods for Medical Devices: The Introduction of a Design for FDA Approach

2011 ◽  
Author(s):  
Lourdes A. Medina ◽  
Richard A. Wysk ◽  
Gu¨l E. Okudan Kremer
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Medical Devices ◽  
Development Process ◽  
Regulatory Compliance ◽  
Design For Manufacturing ◽  
Design For X ◽  
Device Development ◽  
Unites States ◽  
Fda Regulations

This paper focuses on the importance of the regulations, in particular the Food and Drug Administration (FDA), in the development of medical devices. The FDA regulates medical devices to assure that these products are safe and effective before their release into the Unites States market. We introduce the concept of Design for FDA (DfFDA) and describe DfFDA guidelines for medical device development. While many researchers describe the regulations in the form of reviews and models, the literature to date has not reported a DfFDA method. Here, DfFDA is proposed as a method to be used in parallel with other DfX methods when applicable. The DfX methods identified include: Design for Validation (DfV), Design for Reliability (DfR), Design for Quality (DfQ), Design for Manufacturing (DfM), Design for Assembly (DfA) and Design for Usability (DfU). This paper also reviews the literature addressing the FDA regulations and DfX methods, and an overview of the FDA regulations is presented. DfFDA is developed to increase awareness about regulatory compliance and promote designers to consider the regulations throughout the development process of medical devices.

HIPAA Security and Privacy Rules Auditing in Extreme Programming Environments

2020 ◽  
pp. 1341-1363
Author(s):  
Mahmood Alsaadi ◽  
Malik Qasaimeh ◽  
Sara Tedmori ◽  
Khaled Almakadmeh
Keyword(s):  
Case Studies ◽  
System Development ◽  
Software Process ◽  
Security And Privacy ◽  
Extreme Programming ◽  
Evaluation Theory ◽  
Programming Environments ◽  
Common Criteria ◽  
Proposed Model ◽  
Agile Software

Healthcare business is responsible of keeping patient data safe and secure by following the rules of the federal Health Insurance Portability and Accountability Act of 1996, (HIPAA). Agile software organizations that deal with healthcare software system face a number of challenges to demonstrate that their process activities conform to the rules of HIPAA. Such organizations must establish a software process life cycle and develop procedures, tools, and methodologies that can manage the HIPAA requirements during the different stages of system development, and also must provide evidences of HIPAA conformity. This paper proposes an auditing model for HIPAA security and privacy rules in XP environments. The design of the proposed model is based on an evaluation theory which takes as its input the work of Lopez ATAM, and the standards of common criteria (CC) concepts. The proposed auditing model has been assessed based on four case studies. The auditing result shows that the proposed model is capable of capturing the auditing evidences in most of the selected case studies.

HIPAA Security and Privacy Rules Auditing in Extreme Programming Environments

2017 ◽  
Vol 9 (1) ◽  
pp. 1-21 ◽  
Author(s):  
Mahmood Alsaadi ◽  
Malik Qasaimeh ◽  
Sara Tedmori ◽  
Khaled Almakadmeh
Keyword(s):  
Case Studies ◽  
System Development ◽  
Software Process ◽  
Security And Privacy ◽  
Extreme Programming ◽  
Evaluation Theory ◽  
Programming Environments ◽  
Common Criteria ◽  
Proposed Model ◽  
Agile Software

Healthcare business is responsible of keeping patient data safe and secure by following the rules of the federal Health Insurance Portability and Accountability Act of 1996, (HIPAA). Agile software organizations that deal with healthcare software system face a number of challenges to demonstrate that their process activities conform to the rules of HIPAA. Such organizations must establish a software process life cycle and develop procedures, tools, and methodologies that can manage the HIPAA requirements during the different stages of system development, and also must provide evidences of HIPAA conformity. This paper proposes an auditing model for HIPAA security and privacy rules in XP environments. The design of the proposed model is based on an evaluation theory which takes as its input the work of Lopez ATAM, and the standards of common criteria (CC) concepts. The proposed auditing model has been assessed based on four case studies. The auditing result shows that the proposed model is capable of capturing the auditing evidences in most of the selected case studies.

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