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Technical report detailing the correlation between IMDRF Essential Principles and AI for health software, including evaluation of applicability, extraction of key concepts, and proposed mapping for regulatory considerations.
Year:
2019
Location:
New Delhi, India
Type of document:
Technical Proposal
Organization:
ITU-T Focus Group on AI for Health, WG-DAISAM
Authors:
Luis Oala, Pradeep Balachandran, Pat Baird, Thomas Wiegand
Target audience:
Regulators, AI for health developers, medical device manufacturers
Period:
2017-2020
Document status:
Draft
Contact emails:
[email protected]; [email protected]; [email protected]; [email protected]
Abstract:
Provides a mapping of IMDRF Essential Principles to aspects of AI for health software
Keywords:
AI4H, IMDRF, SaMD, Regulatory framework, Risk management, Performance evaluation
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Year:
2019
Region / City:
International
Subject:
Medical device adverse event reporting
Document Type:
Proposed document
Organ / Institution:
International Medical Device Regulators Forum (IMDRF)
Author:
IMDRF Adverse Event Terminology Working Group
Intended Audience:
Regulatory authorities, healthcare providers, manufacturers, reporters of adverse events
Period of validity:
Not specified
Approval date:
27th June 2019
Date of Changes:
Not specified
Year:
2020
Region / City:
International
Topic:
Medical device regulation
Document Type:
Final Document
Organization / Institution:
International Medical Device Regulators Forum (IMDRF)
Author:
IMDRF Adverse Event Terminology Working Group
Intended Audience:
Regulatory authorities, medical device manufacturers, healthcare providers
Period of Validity:
Not specified
Approval Date:
18 March 2020
Date of Changes:
Not specified
Year:
2025
Organization:
International Medical Device Regulators Forum (IMDRF)
Type:
Implementation Report
Authors:
IMDRF Management Committee, Authoring Group
Scope:
International medical device regulatory convergence
Document Series:
IMDRF/MC/N84
Related Documents:
IMDRF technical documents, GHTF documents
Implementation Status Categories:
Implemented, Partly Implemented, Not Implemented, Not Applicable
Countries Covered:
Brazil, Canada, China, EU, Japan, Russia, Singapore, Switzerland, USA, Argentina, Saudi Arabia, Australia, South Korea, UK
Audience:
Regulatory authorities and stakeholders in medical device regulation
Year:
2018
Region / city:
International
Topic:
Medical device regulation
Document type:
Proposed document
Organization / institution:
International Medical Device Regulators Forum (IMDRF)
Author:
IMDRF UDI WG
Target audience:
Medical device regulators
Period of validity:
Ongoing
Approval date:
12 July 2018
Date of changes:
None
Year:
2014
Region / City:
International
Topic:
Medical Device Submissions
Document Type:
Guidance Document
Organization / Institution:
International Medical Device Regulators Forum (IMDRF)
Author:
IMDRF RPS ToC Working Group
Target Audience:
Medical device industry, regulatory authorities
Implementation Period:
Pre-RPS electronic submission environment
Approval Date:
30 June 2014
Amendment Date:
Not specified
Year:
2015
Region / city:
International
Theme:
Medical device regulation, pilot program
Document type:
Final document
Organization / institution:
International Medical Device Regulators Forum (IMDRF)
Author:
Toshiyoshi Tominaga, IMDRF Chair
Target audience:
Medical device regulators, industry participants
Period of validity:
2015-2016
Date of approval:
8 July 2015
Date of revisions:
N/A
Document Number:
IMDRF/RPS WG (PD1)/N27R2
Status:
Proposed Document
Organization:
International Medical Device Regulators Forum
Authoring Group:
Regulated Product Submissions Table of Contents Working Group
Date:
17 September 2015
Subject:
Medical device regulatory submissions
Scope:
Assembly of IMDRF Table of Contents (ToC) based submissions
Related Standard:
Health Level Seven (HL7) Regulated Product Submission Standard
Related Documents:
IMDRF In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC); IMDRF Non-In Vitro Diagnostic Medical Device Market Authorization Table of Contents (nIVD MA ToC); IMDRF Standard ToC Folder Structure; IMDRF Frequently Asked Questions Document
Submission Types:
Non-IVD Market Authorization; IVD Market Authorization
Participating Regions:
ANVISA; EU; Health Canada; TGA; USFDA; CFDA
Language:
English
Access:
No restrictions on reproduction, distribution or use
Year:
2021
Region / City:
International
Topic:
Medical Device Regulation
Document Type:
Standard Operating Procedures
Organization:
International Medical Device Regulators Forum
Author:
IMDRF Management Committee
Target Audience:
Regulatory Authorities, Medical Device Regulators
Effective Period:
Ongoing
Approval Date:
25 March 2021
Modification Date:
Not specified
Year:
2020
Region / Organization:
IMDRF
Subject:
Medical Device Adverse Event Terminology
Document Type:
Coding Guide / Terminology Reference
Annexes Covered:
A, B, C, D, E, F, G
Authoring Group:
IMDRF AE Working Group
Audience:
Medical device regulators, terminology specialists
Hierarchy Details:
Terms in Annex A, C, D, F, G occur once; Annex B has no hierarchy; Annex E terms may appear at multiple levels
Columns Included:
Level 1 Term, Level 2 Term, Level 3 Term, Code, CodeHierarchy, Definition, Non-IMDRF Code/Term, Status, Status Description, Primary Category, Secondary Category (E only)
Purpose:
Standardizing term definitions and hierarchical coding for adverse events in medical devices
Year:
2017-2020
Region / City:
Honolulu, HI
Theme:
Education, Academic Planning
Document Type:
School Academic Plan
Author:
Cindy Yun-Kim
Target Audience:
Educational staff, administrators, and stakeholders
Period of Effectiveness:
2017-2020
Approval Date:
[Insert date]
Date of Changes:
[Insert date]
Year:
2017-2020
Region / City:
Dover, DE
Subject:
Social Work, Education
Document Type:
Application Package
Institution:
Delaware State University, College of Health and Behavioral Sciences, Department of Social Work
Author:
Delaware State University
Target Audience:
Prospective students for BSW Program
Application Deadline:
March (Sophomore Year)
Admission Notification:
May
Year:
2017-2020
Organization:
International Telecommunication Union (ITU) Telecommunication Standardization Sector
Working Group:
FG-AI4H-N-043, Plenary
Title:
DEL9.1 Update: Mobile Applications
Purpose:
Discussion of security and privacy requirements for AI-based mobile health applications
Contacts:
Manjeet Singh Chalga (ICMR, New Delhi, India), Khondaker A Mamun (CMED Health Ltd., Dhaka, Bangladesh), Aveek De (CMS – Social Impact Specialists, Bangalore, India), Prashant Chugh, Rakesh Singh Rawat, Himani Gandhi, Sameer Ranjan, Bidisha Mandal (C-DOT, New Delhi, India)
Target audience:
Medical and AI researchers, mobile application developers, healthcare stakeholders
Scope:
Mobile AI tools for healthcare
Security focus:
Data privacy, encrypted inference, secure communication, regulatory compliance
Platform:
Mobile devices, compatibility with Google Play and Apple App Store
Validation:
Performance benchmarking, usability, security audits, privacy preservation techniques
Year:
2017-2020
Academic Programs:
Business Management, Business Administration, eBusiness, Entrepreneurship, International Business, Finance, International Logistics and Transportation
Document Type:
Assessment Timeline / Curriculum Evaluation
Institution:
Unspecified Academic Institution
Courses Included:
BUS100, BUS120, BUS121, BUS122, BUS123, BUS126, BUS129, BUS134, BUS136, BUS140, BUS142, BUS143, BUS145, BUS148, BUS149, BUS150, BUS151, BUS152, BUS173, BUS174, BUS177
Assessment Period:
Fall 2018 – Fall 2019
Student Learning Outcomes:
Course-level SLOs for multiple business courses
Target Audience:
Students enrolled in the specified programs
Assessment Cycle:
3-Year Cycle (APR/SLO)
Measures:
Reports, presentations, analyses, financial statements, ethical evaluations, market research
Year:
2017-2020
Location:
Geneva, Switzerland
Subject:
Telecommunication standardization, study group procedures
Document type:
Draft recommendation
Organization:
International Telecommunication Union, Telecommunication Standardization Sector
Author:
TSAG Rapporteur, Stephen J. Trowbridge
Target audience:
ITU-T study groups, telecommunication administrations, recognized operating agencies
Approval date:
23-27 September 2019
Edition:
Draft revised Recommendation ITU-T A.1
Keywords:
Working methods, study groups, ITU-T, contributions, TDs, rapporteurs, joint coordination
Abstract:
Consolidated draft of ITU-T A.1 detailing procedures for meetings, study preparation, group management, coordination, and processing contributions
Year:
2017
Organization:
Environment and Climate Change Canada (ECCC)
Document Type:
Action Plan
Subject:
Workplace Mental Health
Authors:
Mental Health Joint Working Group
Period Covered:
2017-2020
Target Audience:
ECCC employees and management
Related Standards:
National Standard of Canada for Psychological Health and Safety in the Workplace
Planned Activities:
Awareness campaigns, training, panel discussions, assessment through surveys
Key Outcomes:
Employee empowerment, manager support, stigma reduction, integration of mental health into workplace practices
Context:
Canadian federal public service initiatives on mental health in the workplace
Description:
Government action plan detailing strategic initiatives, key activities, and outcomes for improving mental health and psychological safety at ECCC workplaces over a three-year period.
Att.1 – TDD update (TG-FakeMed) for AI-based detection of falsified medicine, Study Period 2017-2020
Year:
2021
Organization:
International Telecommunication Union, Telecommunication Standardization Sector
Study Period:
2017-2020
WG(s):
Plen
Meeting:
Online, 19-21 May 2021
Source:
TG-FakeMed Topic Driver
Document Type:
Topic Description Document (TDD)
Author / Contact:
Frank Verzefé, TrueSpec-Africa, DRC, [email protected]
Focus:
AI for detection of substandard and falsified medical products
Purpose:
Discussion and development of AI benchmarking methods
Abstract:
Description of objectives, methodology, data structure, and benchmarking approach for AI in detecting falsified medicines
Scope:
Global, with emphasis on public health impact and data collection from LMICs
Ethical Considerations:
Data quality, accuracy, database management, and impact assessment
Year:
2017-2020
Country:
Namibia
Project Type:
Disability Inclusion Initiative
Participating Organizations:
UNFPA, UNICEF, UNESCO, UNDP
Target Group:
Persons with Disabilities (PWDs)
Budget:
USD 400,000
Duration:
36 months
Legal Framework:
Convention on the Rights of Persons with Disabilities (CRPD), Optional Protocol, Sustainable Development Goals (SDGs)
Responsible Institutions:
Ministry of Gender Equality and Child Welfare, Ministry of Education, Arts and Culture, Ministry of Health and Social Services, Office of the President, Disability Affairs
Focus Areas:
Data collection, early childhood interventions, national monitoring, partnership coordination
Population Statistics:
PWDs population 85,000–100,000 (5% of total), majority aged 10–24, higher rural incidence of school non-attendance
Gender Analysis:
Female PWDs face higher barriers in education and exposure to violence
Socioeconomic Context:
Upper Middle Income Country, high income inequality (Gini 0.597), 60% of population affected by poverty
Data Sources:
Namibia Demographic and Health Survey 2013, Namibia 2011 Population and Housing Census, WHO, World Bank
Year:
2018
Region / City:
San Joaquin Valley, California
Topic:
Healthcare, Agricultural Industry
Document Type:
Report
Organization:
Diringer and Associates, California Rural Legal Assistance Foundation
Author:
Joel Diringer, JD, MPH, Noe Paramo, JD
Target Audience:
Agricultural workers, policymakers, public health professionals
Period of Action:
April 2018
Date of Approval:
April 2018
Date of Changes:
N/A
Contextual Description:
A report examining the impact of Medi-Cal expansion on farmworkers in San Joaquin Valley, addressing both health coverage and economic consequences for agricultural employers.
Institution:
Wayne State University
Program:
Physical Therapy Program
Document type:
Program policy and standards
Subject area:
Physical therapy education
Purpose:
Admission, retention, and graduation requirements
Applicable settings:
Classroom, laboratory, tutorial, and clinical settings
Regulatory and professional references:
American Physical Therapy Association; Commission on Accreditation for Physical Therapy Education
Intended audience:
Physical therapy students and applicants
Professional scope:
Entry-level generalist physical therapy practice
Ethical framework:
Ethical and safe clinical practice standards
Standards categories:
Academic, clinical, physical, and interpersonal abilities
Academic source type:
Institutional academic policy defining professional competency standards
Year:
2026
Region / City:
Brent, London
Type of Document:
Application form
Issuing Authority:
Brent Council
Target Audience:
Charitable organisations and public sector workers providing essential services
Eligibility:
Statutory service workers, NHS employees, home-visiting staff of religious or non-profit organisations
Vehicle Requirements:
Maximum length 6.5m, maximum height 2.5m, maximum weight 5 tonnes
Usage Restrictions:
Only during official duties, not within 750 metres of workplace, not in restricted bays
Application Requirements:
Completed form with applicant and employer declarations
Data Protection:
Personal and vehicle data collected under Data Protection Act for traffic administration and fraud prevention