Standards in Telemedicine
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
Artificial Intelligence in Health Care: the Hope, the Hype, the Promise, the Peril
Artificial Intelligence in Health Care: The Hope, the Hype, the Promise, the Peril Michael Matheny, Sonoo Thadaney Israni, Mahnoor Ahmed, and Danielle Whicher, Editors WASHINGTON, DC NAM.EDU PREPUBLICATION COPY - Uncorrected Proofs NATIONAL ACADEMY OF MEDICINE • 500 Fifth Street, NW • WASHINGTON, DC 20001 NOTICE: This publication has undergone peer review according to procedures established by the National Academy of Medicine (NAM). Publication by the NAM worthy of public attention, but does not constitute endorsement of conclusions and recommendationssignifies that it is the by productthe NAM. of The a carefully views presented considered in processthis publication and is a contributionare those of individual contributors and do not represent formal consensus positions of the authors’ organizations; the NAM; or the National Academies of Sciences, Engineering, and Medicine. Library of Congress Cataloging-in-Publication Data to Come Copyright 2019 by the National Academy of Sciences. All rights reserved. Printed in the United States of America. Suggested citation: Matheny, M., S. Thadaney Israni, M. Ahmed, and D. Whicher, Editors. 2019. Artificial Intelligence in Health Care: The Hope, the Hype, the Promise, the Peril. NAM Special Publication. Washington, DC: National Academy of Medicine. PREPUBLICATION COPY - Uncorrected Proofs “Knowing is not enough; we must apply. Willing is not enough; we must do.” --GOETHE PREPUBLICATION COPY - Uncorrected Proofs ABOUT THE NATIONAL ACADEMY OF MEDICINE The National Academy of Medicine is one of three Academies constituting the Nation- al Academies of Sciences, Engineering, and Medicine (the National Academies). The Na- tional Academies provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. -
Don't Risk It! ISO 13485:2016 and How to Determine Compliance Level
Don’t Risk It! ISO 13485:2016 and How to Determine Compliance Level August 18, 2016 John Beasley, RAC(US) MedTech Review, LLC Thought of the Day: “Act after having made assessments. The one who first knows the measure of far and near wins.” - Sun Tzu, The Art of War 2 Today’s Topics • Overview of changes in ISO 13485, 3rd Edition – Risk management – Usability – Outsourced processes • Supplier evaluation – determining LSP level of compliance • Concluding remarks • Q&A ISO 13485:2016 1 Overview of Changes in the 3rd Edition History of ISO 13485 13485 13485 13485 9001 9001 9001 1994 / 2000 / 2003 2015 / 1996 2008 / 2009 2016 5 Publication History 1996 - Publication of standards ISO 13485 and ISO 13488. • 13485 variant intended for manufacturers responsible for design, manufacture and distribution of devices. • 13488 variant intended for manufacturers not responsible for designing devices. Variants must be used with ISO 9001:1994 and ISO 9002:1994 as applicable. 2003 - Publication of 2nd edition ISO 13485:2003. Considered to be “stand alone”. ISO 13488 now obsolete. Organizations that previously used 13488 must now use 13485 but can exclude section 7.3 “design and development” if allowed by regulations. Device specific requirements that do not apply to the manufacturer are tagged as “not applicable”. 6 Publication History 2004 - Publication of guidance document ISO/TR 14969. Its purpose is to provide a single source of guidance on the interpretation and implementation of 13485. 2009 - Corrigendum to 13485:2003 published to change reference from ISO 9001:2000 to ISO 9001:2008. 2012 - CEN (European standards organization) publishes EN ISO 13485:2012 as the European adoption of ISO 13485:2003 (2009 corrigendum). -
Openfog Reference Architecture for Fog Computing
OpenFog Reference Architecture for Fog Computing Produced by the OpenFog Consortium Architecture Working Group www.OpenFogConsortium.org February 2017 1 OPFRA001.020817 © OpenFog Consortium. All rights reserved. Use of this Document Copyright © 2017 OpenFog Consortium. All rights reserved. Published in the USA. Published February 2017. This is an OpenFog Consortium document and is to be used in accordance with the terms and conditions set forth below. The information contained in this document is subject to change without notice. The information in this publication was developed under the OpenFog Consortium Intellectual Property Rights policy and is provided as is. OpenFog Consortium makes no representations or warranties of any kind with respect to the information in this publication, and specifically disclaims implied warranties of fitness for a particular purpose. This document contains content that is protected by copyright. Copying or distributing the content from this document without permission is prohibited. OpenFog Consortium and the OpenFog Consortium logo are registered trademarks of OpenFog Consortium in the United States and other countries. All other trademarks used herein are the property of their respective owners. Acknowledgements The OpenFog Reference Architecture is the product of the OpenFog Architecture Workgroup, co-chaired by Charles Byers (Cisco) and Robert Swanson (Intel). It represents the collaborative work of the global membership of the OpenFog Consortium. We wish to thank these organizations for contributing -
Core System Architecture Viewpoints
Core System System Architecture Document (SAD) www.its.dot.gov/index.htm Draft — September 6, 2011 Produced by Lockheed Martin ITS Joint Program Office Research and Innovative Technology Administration U.S. Department of Transportation Notice This document is disseminated under the sponsorship of the Department of Transportation in the interest of information exchange. The United States Govern- ment assumes no liability for its contents or use thereof. Report Documentation Page Form Approved OMB No. 0704-0188 The public reporting burden for this collection of information is estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden, to Department of Defense, Washington Headquarters Services, Directorate for Informa- tion Operations and Reports (0704-0188), 1215 Jefferson Davis Highway, Suite 1204, Arlington, VA 22202-4302. Respondents should be aware that notwithstanding any other provision of law, no person shall be subject to any penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. PLEASE DO NOT RETURN YOUR FORM TO THE ABOVE ADDRESS. 1. REPORT DATE (DD MM YYYY) 2. REPORT TYPE 3. DATES COVERED 06 09 2011 (Draft Specification) Month YYYY – Month YYYY 4. TITLE AND SUBTITLE 5a. CONTRACT NUMBER Core System: System Architecture Document (SAD) Draft GS-23F-0150S 5b. GRANT NUMBER Xxxx 6. AUTHOR(S) 5c. PROGRAM ELEMENT NUMBER Core System Engineering Team Xxxx 5d. -
Regulatory Feasibility Analysis for a New Atrial Fibrillation Ablator in Selected Countries
MQP – FRH – FHO2 Regulatory Feasibility Analysis for a New Atrial Fibrillation Ablator in Selected Countries A Major Qualifying Project Report Submitted to the Faculty of the Worcester Polytechnic Institute in partial fulfillment of the requirements for the Degree of Bachelor of Science in Management by ______________________ Matthew Hammond Approved: _______________________ _______________________ Martin Sklar, President and CEO Frank Hoy, Ph.D. AblaCor Medical Corporation Paul R. Beeswick Professor of Project Sponsor Innovation and Entrepreneurship Project Advisor _______________________ Jerome Schaufeld, Ph.D. Professor of Practice Project Co-Advisor 1 | P a g e Abstract Medical device registration for class three devices, such as a catheter ablator, can be a long and difficult process. The regulatory requirements can vary greatly by country, overlap and benefit one another, or require repeating a certification depending on the country in question. Determining the order in which to enter specific countries greatly depends on the size of the potential market and the costs and time needed for regulatory approval. Prior approval on major facets such as clinical trials may greatly reduce the costs of entering a particular country if the data from an outside source is deemed acceptable. This creates a complex problem where start- ups who cannot afford to pursue regulatory approval in all major markets simultaneously must carefully chose and enter individual markets a few at a time. The paper will evaluate the regulatory pathways of ten select countries. This regulatory analysis, combined with a market analysis on these same countries by the other three members of the project, will form a basis from which we can create a suggested order of entry. -
Risk Management for Manufacturers of in Vitro Diagnostic Medical Devices
Technical Guidance Series (TGS) Risk management for manufacturers of in 1 TGS–07 vitro diagnostic medical devices Draft for comment 25 September 2017 © World Health Organization 2017 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for non-commercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. -
FDARA Section 710 Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices
May 2018 FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices In accordance with Section 710 of the Food and Drug Administration Reauthorization Act of 2017 (FDARA) Executive Summary The Food and Drug Administration Reauthorization Act (FDARA) became law on August 18, 2017. Section 710 of FDARA charges the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to issue a report on the continued quality, safety, and effectiveness of medical devices with respect to servicing. FDA has considered information including but not limited to the information presented at a public workshop, responses to a request for comments, and evaluation of objective evidence related to the quality, safety, and effectiveness of medical device servicing in the compilation of this report. Stakeholders have differing views about the quality, safety, and effectiveness of servicing performed by original equipment manufacturers (OEMs) and third party entities, and the need for imposing additional regulation. Based on the available information, we have concluded: • The currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing, including by third party servicers, of medical devices that would justify imposing additional/different, burdensome regulatory requirements at this time; • Rather, the objective evidence indicates that many OEMs and third party entities provide high quality, safe, and effective servicing of medical devices; • A majority of comments, complaints, and adverse event reports alleging that inadequate “servicing” caused or contributed to clinical adverse events and deaths actually pertain to “remanufacturing” and not “servicing”; and • The continued availability of third party entities to service and repair medical devices is critical to the functioning of the U.S. -
Phihong Ev Chargers 2021-2022
2021-2022 PHIHONG EV CHARGERS World Class Quality, International Standards Phihong Technology Co., Ltd is a core member of the organization Charging Interface Initiative e. V. (CharIN e. V.) and member of CHAdeMO Association. The goal is to promote and continuously develop the Combined Charging System (CCS) also ensuring compatibility between the infrastructure and the EVs. PHTV2102E Phihong Technology Phihong is a leading global power products manufacturer with over 50 years of industry experience. As a supplier to many of the world’s leading brands, Phihong continues to design innovative products with an emphasis on envi- ronmental protection and carbon reduction. Phihong offers a complete product line of EV charging OEM/ODM - AC Chargers solutions supporting both commercial and passenger electric vehicles. This includes Level 3 DC chargers ranging from 30kW to 360kW and Level 2 AC EVSE rang- ing from 16 to 48 amps. In addition, Phihong offers DC charging modules, auxiliary power, control & supervisor units (CSU), discrete type DC chargers, integrated type DC chargers, moveable DC chargers, and portable DC chargers. Phihongs EV charging software solutions include a front- OEM/ODM - DC Chargers end mobile APP and user interface (HMI) and a cloud- based management, payment, and monitoring platform. Through the front-end mobile APP, people can search for nearby chargers, schedule charging appointments, and monitor charging status. System operators can monitor the status of individual EV chargers and remotely up- date them, enabling long-term maintenance and man- agement. With strong R&D design capabilities and solid manufacturing experience, Phihong Technology delivers high-quality and cost-effective hardware/software prod- Modules ucts based on specific customer needs. -
ANSI/IEEE 1471 and Systems Engineering•
ANSI/IEEE 1471 and Systems Engineering• Mark W. Maier David Emery The Aerospace Corporation The MITRE Corporation 15049 Conference Center Dr 7515 Colshire Drive, MS N110 Chantilly, VA 20151 McLean, VA 22102-3481 [email protected] [email protected] Rich Hilliard P.O. Box 396 Littleton, MA 01460 [email protected] Abstract: ANSI/IEEE Standard 1471-2000 is the Recommended Practice for Architectural Description of Software- Intensive Systems, developed by the IEEE’s Architecture Working Group (AWG) under the sponsorship of the Software Engineering Standards Committee of IEEE. ANSI/IEEE 1471 is the first formal standard1 to address the content and organization of architectural descriptions. The standard defines the structure and content of an architectural description (AD) and incorporates a broad consensus on best practices for such descriptions. Although ANSI/IEEE 1471 was conceived as a software-focused standard, this paper argues that it is equally applicable to any system; hence appropriate for use as a part of systems engineering to describe system architectures. This article reviews the concepts of ANSI/IEEE 1471, the rationale for their selection, and demonstrates its application in systems engineering. ARCHITECTURE FRAMEWORKS The notion of architecture has entered into both the domains of software and systems engineering in recent decades. There are several threads to this entry. Many invoke a direct analogy with the notion in civil engineering, while others are built on particular practices largely drawn from the information technology industry. Some background on what problems are being addressed by what goes by the term “architecture” is helpful in understand the motivation for the ANSI/IEEE 1471 work and related frameworks. -
Annual Report 2020 PDF Data
Contents KWE Group Corporate Guidelines (1) We strive to further increase corporate value by delivering 02 Aiming for Sustainable Growth customers quality services that meet their needs and earn their confidence. 06 Foundation for Creating New Value (2) We strive to be an organization that grows and expands through logistics business. 08 Top Message (3) We promote communications with stakeholders and disclose corporate information accurately and 15 Report by Six Segments appropriately. (4) We are committed to comply with external regulations, 21 Sustainability Management and compliance monitoring and assessment are built into all levels of the business. 36 Management’s Discussion and Analysis (5) We ensure a safe and healthy work environment where 43 Financial Highlights people are treated respectfully and fairly. (6) We contribute in sustainable community development, 44 Financial Statements with attention to global environmental issues. 62 Investor Information Guide to Buttons Move Back to Previous Page Expectations and Forecasts This annual report contains statements about our expectations and forecasts regarding plans, strategies, and business results related to the future of Kintetsu World Express, Move Forward to Next Page Inc. (KWE). These statements reflect our expectations based on personal beliefs and assumptions that were determined in light of information that was available at the time Print Search PDF Content the report was prepared. There are innumerable risk factors and uncertainties that could affect the future, including economic trends, competition in the logistics industry, market conditions, fuel prices, exchange rates, and tax or other regulatory system considerations. Go to Contents Page Please be well advised that because of these risk factors, actual results may differ from our expectations. -
An Overview of IEEE Software Engineering Standards and Knowledge Products
An Overview of IEEE Software Engineering Standards and Paul R. Croll Knowledge Products Chair, IEEE SESC Computer Sciences Corporation [email protected] Objectives l Provide an introduction to The IEEE Software Engineering Standards Committee (SESC) l Provide an overview of the current state and future direction of IEEE Software Engineering Standards and knowledge products u IEEE Software Engineering Standards Collection u Software Engineering Competency Recognition Program u Standards-Based Training l Discuss how you can participate in software engineering standardization efforts ASQ Section 509 SSIG Meeting, 8 November 2000 Paul R. Croll - 2 The IEEE Software Engineering Standards Committee (SESC) http://computer.org/standard/sesc/ ASQ Section 509 SSIG Meeting, 8 November 2000 Paul R. Croll - 3 The SESC Vision l The leading supplier and promoter of a family of software engineering standards and related products and services. ASQ Section 509 SSIG Meeting, 8 November 2000 Paul R. Croll - 4 Software Engineering: An Object View Source: [SESC95] ASQ Section 509 SSIG Meeting, 8 November 2000 Paul R. Croll - 5 SESC in the IEEE Structure IEEE IEEE IEEE Computer Society Standards Board Software Engineering Standards Committee Executive Committee & Management Board Working Group Study Group Planning Group Conferences ASQ Section 509 SSIG Meeting, 8 November 2000 Paul R. Croll - 6 SESC Strategic Program Model ISO and IEC IEEE SESC Standards Standards Program Terminology Terminology Overall Guide Quality Customer Resource Process Product Management Principles or Policies Element Standards Software Engineering Application Guides System “Toolbox” of Disciplines Technique Standards Source: [SESC95] ASQ Section 509 SSIG Meeting, 8 November 2000 Paul R. Croll - 7 The IEEE Software Engineering Standards Collection http://standards.ieee.org/catalog/softwareset.html ASQ Section 509 SSIG Meeting, 8 November 2000 Paul R. -
US FDA System Regulation Vs. ISO 13485:2016 Quality
US FDA QUALITY SYSTEM REGULATION VERSUS ISO 13485:2016 QUALITY MANAGEMENT SYSTEM REQUIREMENTS NSF INTERNATIONAL 21 CFR § 820 & ISO 13485:2016 ALIGNMENT CHART Author: Robert Ruff, Executive Director, NSF International Researcher: Samuel Brown, Research Associate, NSF International This tool clarifies the corresponding relationships between the US FDA Quality System Regulation and ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes clauses. Use this tool to ensure your quality management system meets applicable requirements of both US FDA and ISO 13485:2016 21 CFR § 820 US FDA QUALITY SYSTEM REGULATION ISO 13485:2016 SPECIFIC DIFFERENCES 820.1 Scope 1 Scope Each manufacturer shall establish and 4.1.1 Quality maintain a quality system that is appropriate 820.5 Quality management for the specific medical device(s) designed No significant difference in requirements. System system, General or manufactured, and that meets the requirements requirements of this part. Management with executive responsibility shall establish its policy and objectives for, ISO 13485:2016 specifies additional detail and commitment to, quality. Management 5.3 Quality Policy 820.20(a) relative to quality policy. For example: 5.3 b), with executive responsibility shall ensure Quality Policy 5.4.1 Quality 5.3 e). ISO 13485:2016 specifically requires that the quality policy is understood, Objectives the quality objectives to be measurable. implemented, and maintained at all levels of the organization. Each manufacturer shall establish and maintain an adequate organizational structure 5.5.1 820.20(b) to ensure that devices are designed and Responsibility and No significant difference in requirements. Organization produced in accordance with the requirements Authority of this part.