Health and Healthcare in the Fourth Industrial Revolution Global Future Council on the Future of Health and Healthcare 2016-2018
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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. -
Artificial Intelligence: the Key to Unlocking Novel Real-World Data?
Artificial Intelligence: The Key to Unlocking Novel Real-World Data? While Artificial intelligence stands to make significant contributions to clinical research due to its unparalleled ability to translate unstructured data into real-world evidence (RWE), significant challenges remain in achieving regulatory-grade evidence. By Michele Cleary 16 | March/April 2019 Value & Outcomes Spotlight Artificial intelligence (AI) is revolutionizing healthcare services. From improving disease detection to supporting treatment decision making, AI has become ubiquitous in care delivery. Now AI is poised to transform the drug and device development process, helping researchers refine the approval process and significantly cutting both the time and the expense needed to bring products to market. While AI has long been used to facilitate recruitment of study subjects, optimize study design, and support patient adherence to study protocols, AI’s greatest contribution to clinical research may still be on the horizon— unlocking the data richness that lies within the mountains of novel real- world data (RWD) sources. This article explores how AI may improve clinical research through its ability to better translate RWD into real-world evidence (RWE), thus providing more valid evidence of clinical benefits and risks. Dan Riskin, MD, of Verantos, Rich Glinklich, MD of OM1, and Sebastian Schneeweiss, MD of Aetion all shared their valuable insights into how AI is transforming clinical research. THE SEARCH FOR REGULATORY-GRADE DATA With innovations in digital data, HEOR researchers are facing explosive growth in novel RWD sources. But as researchers move from traditional RWD sources (eg, registries and claims data) to these novel data sources, unstructured data present a significant opportunity and challenge. -
All Pakistan Women Chambers' Presidents Call on Sania Nishtar To
Government of Pakistan Poverty Alleviation and Social Safety Division Press Release All Pakistan Women Chambers’ Presidents call on Sania Nishtar to seek partnership under Ehsaas December 3, 2019- Islamabad: Presidents of all Pakistan Women Chambers accompanied by leadership of Rawalpindi Chamber of Commerce and Industry called on Dr. Sania Nishtar, Special Assistant to the Prime Minister on Social Protection and Poverty Alleviation at the Prime Minister’s Secretariat. The meeting took stock of key challenges and opportunities for women entrepreneurs around economic activities in the country and explored options for supporting the Women Chambers under the Ehsaas that is the multisectoral antipoverty programme of the Government. The entrepreneurial women leaders from 11 Women Chambers all across Pakistan came to the table immediately following their interaction with Dr. Nishtar at the inauguration of a three day Third All Pakistan Women Chambers Presidents’ Summit (APWCPS) in Rawalpindi. Presidents and members of Women Chambers flagged the need for institutional support to run the secretariats of the Chambers. Dr. Nishtar assured them that it will be explored at the highest level. Women Chambers were briefed about the new Financial Inclusion Policy of Ehsaas and Dr. Sania assured them that a briefing will be arranged for members of the Women Chambers so that they can better understand how to access credit through the window of Ehsaas. In addition, they reiterated the need for support through Export Development Fund. Dr. Nishtar reassured them that this will be discussed with the Ministry of Commerce for further necessary action. “In order for us to succeed as a country and grow our economy, we need many more women in Pakistan to have opportunities to learn, earn and thrive,” Dr. -
Using Real World Data in Pharmacoeconomic Evaluations
Using Real World Data in Pharmacoeconomic Evaluations: Challenges, Opportunities, and Approaches Andreas M. Pleil, PhD Senior Director Worldwide Medical and Outcomes Research Pfizer, Inc., La Jolla, CA Slide:2 Disclaimer and Acknowledgements The opinions expressed by the presenter are his and may not reflect the opinions or position of Pfizer, Inc., it’s Board or Management Many thanks to Lou Garrison for allowing me to steal many of these slides shamelessly Slide:3 Today’s Agenda Overview of the Landscape Where do data come from Report from the Task Force What was their charge Who did the charging What did they conclude Discussion points Is the RWTF sufficient Are there gaps in our knowledge What should we do next Applications from your world Group Project Slide:4 Where do “Data” Come From? Pre-clinical studies Provides a first assessment of the expected safety and efficacy of a compound using proven animal models Early Phase Clinical trials IND Safety focus and the beginnings of efficacy, dose ranging, and tolerability Pivotal Clinical trials Demonstrate safety and efficacy in well controlled (generally masked) randomized studies sufficient for market authorization NDA Filed Phase IIIB Expanded trials in different use situations NDA Approved or populations Phase IV Post marketing safety or “new” indications Real World Data Evaluations of safety, effectiveness and outcomes in “routine” clinical practice Slide:5 Who uses “Data”? Companies making internal decision regarding drug development Regulators responsible -
Prime Minister Imran Khan Complaint Cell App
Prime Minister Imran Khan Complaint Cell App Supplest and surrounded Chelton prancings briskly and accouter his museology globally and discreditably. Unvitrified Iain still intellectualized: nepenthean and gearless Marcello chronicle quite bovinely but influence her ripplers tigerishly. Izzy homes her lysozyme grandiosely, she undrew it harrowingly. Besides prominent members of minister imran ismail at panagah, certificates to delivering institutional reform with six candidates of karachi under khan. Kindly solution to perform their mobiles where prime minister imran khan complaint cell app in areas to the most vulnerable population of the effect will also visited an iron hand. February at islamabad and the cabinet also joined for the special assistant to solve the urban poor children in the introductory presentations by illegal immigrant in attendance by minister imran has. The PM also interacted with several daily wagers over had dinner and inquired about facilities being provided to mate at the Panagah. The honey is celebrated to addition the literacy agenda towards a more abnormal and sustainable society. She directed the staffers at the centres not open make doll stand the long queues to avail the facility. Pakistan imran khan complaint cell is an app. Sania Nishtar, from Heartfile. An awareness about the imran khan saying he heard their stories of prime minister imran khan complaint cell app features of international trust in firewall settings section judge issue. Stay at the app was briefed by prime minister imran khan complaint cell app will be formalized soon commence registration desks set for. Azerbaijan exempts grain and prime minister imran khan complaint cell app? Sania nishtar took place a person wants to the event fomented keen interest free loan cheque distribution being associated with secretary. -
Generating Real-World Evidence by Strengthening Real-World Data Sources
Generating Real-World Evidence by Strengthening Real-World Data Sources Using “real-world evidence” to bring new “Every day, health care professionals are updating patients’ treatments to patients as part of the 21st electronic health records with data on clinical outcomes Century Cures Act (the “Cures Act”) is a key resulting from medical interventions used in routine clinical priority for the Department of Health and practice. As our experience with new medical products Human Services (HHS). Specifically, the Cures expands, our knowledge about how to best maximize their Act places focus on the use of real-world data benefits and minimize potential risks sharpens with each data to support regulatory decision-making, including point we gather. Every clinical use of a product produces data the approval of new indications for existing that can help better inform us about its safety and efficacy.” drugs in order to make drug development faster jacqueline corrigan-curay, md, jd and more efficient. As such, the Cures Act director of the office of medical policy in fda’s center for drug evaluation and research has tasked the Food and Drug Administration (FDA) to develop a framework and guidance for evaluating real-world evidence in the context of drug regulation.1 Under the FDA’s framework, real-world evidence (RWE) is generated by different study designs or analyses, including but not limited to, randomized trials like large simple trials, pragmatic trials, and observational studies. RWE is the clinical evidence about the use, potential benefits, and potential risks of a medical product based on an analysis of real-world data (RWD). -
Using Real-World Evidence to Accelerate Safe and Effective Cures Advancing Medical Innovation for a Healthier America June 2016 Leadership Senator William H
Using Real-World Evidence to Accelerate Safe and Effective Cures Advancing Medical Innovation for a Healthier America June 2016 Leadership Senator William H. Frist, MD Former U.S. Senate Majority Leader Chair, FDA: Advancing Medical Innovation Bipartisan Policy Center Representative Bart Gordon Former Member, U.S. House of Representatives Chair, FDA: Advancing Medical Innovation Bipartisan Policy Center Advisory Committee Marc M. Boutin, JD Chief Executive Officer National Health Council Mark McClellan, MD, PhD Director, Robert J. Margolis Center for Health Policy Duke University Patrick Soon-Shiong, MD Chairman and Chief Executive Officer Institute for Advanced Health Andrew von Eschenbach, MD President Samaritan Health Initiatives 1 Sta G. William Hoagland Ann Gordon Senior Vice President Writer Bipartisan Policy Center Michael Ibara, PharmD Janet M. Marchibroda Independent Consultant Director, Health Innovation Initiative and Executive Director, CEO Council on Health and Innovation Bipartisan Policy Center Tim Swope Senior Policy Analyst Bipartisan Policy Center Sam Watters Administrative Assistant Bipartisan Policy Center 2 FDA: ADVANCING MEDICAL INNOVATION EFFORT The Bipartisan Policy Center’s initiative, FDA: Advancing Medical Innovation, is developing viable policy options to advance medical innovation and reduce the time and cost associated with the discovery, development, and delivery of safe and effective drugs and devices for patients in the United States. Key areas of focus include the following: Improving the medical product development process; Increasing regulatory clarity; Strengthening the Food and Drug Administration’s (FDA) ability to carry out its mission; Using information technology to improve health and health care; and Increasing investment in medical products to address unmet and public health needs. -
Korea Sukyeong Kim, Phd Senior Research Fellow, International Cooperation Advisor Evidence-Based Healthcare Research Division
Real World Evidence and Local Evidence Generation: How Should it Be Approached in Asia Pacific? - Korea Sukyeong Kim, PhD Senior Research Fellow, International Cooperation Advisor Evidence-based Healthcare Research Division Real World Data & Real World Evidence • Real World Data o The data relating to patient health status and/ or the delivery of health care routinely collected from a variety of sources • Electronic health records (EHRs) • Claims and billing activities • Product and disease registries • Patient-related activities in out-patient or in-home use settings • Health-monitoring devices • Real World Evidence o The clinical evidence regarding the usage and potential benefits or risks of medical product derived from analysis of Real World Data FDA. Real World Evidence. https://www.fda.gov/ScienceResearch/SpecialTopics/RealWorldEvidence/default.htm 2 1 NHI system and Real World Data • National Health Insurance System o Operating based on Electronic Data Interchange and web-base claims submission 3 Real World Data • Medical Record o Electronic Medical Record in Hospitals and Clinics • Facilitated by electronic National Health Insurance Claims Review and Assessment system building • Tertiary hospitals have been leading Electronic Medical Record and hospital Information and Communication System • Medium and small hospitals and clinics adopted EMR system around 97% in 2014 4 2 Real World Data • National Health Insurance Information System o Electronic NHI Claims Review and Assessment System • Based on web-based claims submission 5 Real -
Dr. Sania Inaugurates Ehsaas Innovative Digital Payment System for Poorest Women in KP
Dr. Sania inaugurates Ehsaas innovative digital payment system for poorest women in KP Jan 27, 2020, Dr. Sania Nishtar, Prime Minister’s Special Assistant on Social Protection and Poverty Alleviation visited a branch of Bank Alfalah located at Shuba Chowk in Peshawar to oversee final preparations for the launch of the new Kafalat cash-transfer program, which will enable cash disbursements of Ehsaas Kafalat Programme. Sitting under the umbrella of Ehsaas, the Kafalat programme will use a fully biometric payment system to provide safe, digital cash payments to millions of women across the country, giving them access to a bank account for the first time in their lives. “The Ehsaas Kafalat programme is a major component of the government’s plans to build a welfare state which supports the poorest in society”, said Dr. Sania Nishtar during the visit. During the visit, Dr. Nishtar observed how Bank Alfalah plans to provide a welcoming environment for those people who have not previously used a bank, including their methods for guiding beneficiaries through the new system of finger-print security. Footage can be accessed here. Pakistan Post Foundation helps deliver new flagship Ehsaas Kafalat Jan 27, 2020, Preparations for the new Kafalat cash-transfer programme are well underway at the Pakistan Post Foundation, with eligibility letters ready to be delivered to the first wave of beneficiaries across the country. The process of readying the official letters for distribution was inspected during a visit over the weekend by Special Assistant to the Prime Minister on Social Protection and Poverty Alleviation, Dr. Sania Nishtar and Federal Minister for Communications and Postal Services, Murad Saeed. -
Financial Inclusion
ANNUAL REPORT TO THE SECRETARY-GENERAL SEPTEMBER 2020 UNITED NATIONS SECRETARY-GENERAL’S SPECIAL ADVOCATE FOR INCLUSIVE FINANCE FOR DEVELOPMENT FINANCIAL INCLUSION Beyond Access and Usage to Quality TABLE OF CONTENTS Message from the UNSGSA � � � � � � � � � � � � � � � � � � � � � � � � � 2 The Path of Financial Inclusion � � � � � � � � � � � � � � � � � � � � � � 4 Ensuring Positive Impact on Development � � � � � � � � � � � � � � � � � � � � � � 6 Reaching the Underserved � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 8 Responsible Tech Solutions � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �13 CEO Partnership for Economic Inclusion � � � � � � � � � � � � �18 Country Visits Pakistan � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 22 Indonesia � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 27 Financial Inclusion for Development: Building on 10 Years of Progress � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �28 The Road Ahead � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �32 Annexes � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �34 About the UNSGSA � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 35 UNSGSA Activities 2019–2020 � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 36 Cover photo credit: Hesham Fathy Message from the UNSGSA The state of the -
Premier Healthcare Database
WHITE PAPER: PREMIER HOSPITAL DATABASE (PHD) – March 2, 2020 Premier Healthcare Database: Data That Informs and Performs Premier Applied Sciences®, the Research Division of Premier Inc. March 2, 2020 This white paper provides a detailed description of the attributes and capabilities of the Premier Healthcare Database (PHD), which has been utilized by the pharmaceutical and device industries, academia, healthcare insurers and healthcare policy makers For clinical, financial and outcomes analyses. Since the year 2000, more than 600 publications in peer- reviewed journals – the gold standard for publishing research – have included more than 110 articles written by Premier stafF in multiple therapeutic and quality improvement/patient safety areas (Premier Applied Sciences® website). Details on data source, type and scope are outlined. Premier Applied Sciences® is the Research Division of Premier Inc. and is responsible For leveraging the HIPAA-compliant PHD through its highly proFessional and experienced team. SUGGESTED CITATION: Premier Healthcare Database White Paper: Data that informs and performs, March 2, 2020. Premier Applied Sciences®, Premier Inc. https://learn.premierinc.com/white-papers/premier-healthcare- database-whitepaper. 1 WHITE PAPER: PREMIER HOSPITAL DATABASE (PHD) – March 2, 2020 INTRODUCTION Electronic healthcare databases house “big data” and offer several advantages as a robust research tool1-3. A comprehensive hospital-based healthcare history of each patient in the healthcare system may be available. Patients and physicians are not involved in data collection, thus eliminating potential bias that may come with being observed. Since data accrues from a large diverse population, rare outcomes and long-term effects can be studied. The data reflects the state of clinical practice in the general population. -
Optimizing Rwe Generation Fda's
appliedclinicaltrialsonline.com Volume 28 Number 4 April 2019 YOUR PEER-REVIEWED GUIDE TO GLOBAL CLINICAL TRIALS MANAGEMENT 1992–2019 ACTAACCT 2727 e Year c of Servi STUDY DESIGN OPTIMIZING RWE GENERATION REGULATORY For personal, non-commercial use FDA’S ‘REAL-WORLD’ FRAMEWORK DATA SHARING ADOPTING GLOBAL DATA STANDARDS WASHINGTON REPORT EU REPORT CLOSING THOUGHT The Push to Broaden Clinical Translational Research Message Rise of the ‘Citizen Trial Eligibility Criteria Lost in Transmission Data Scientist’ FROM THE EDITOR Emerging Biopharma Deserve TLC from CROs arly this month, I presented on the topic was 26%, compared to 60% that went to firms that had never before E“Why Aren’t Lessons Learned from Big received an approval. Pharma/Big CROs Translating to Smaller The days of quickly selling a promising compound early on to a large Biopharma Relationships?” For years, Applied pharma company or launching a full-fledged IPO are dwindling. An Ernst Clinical Trials has been the operational re- & Young report showed 75 biotech IPOs in 2014 compared to nine in the source for clinical trials for sponsors, CROs, second half of 2016. These days, innovation hubs in major regions of the and academia. The transition of the contract country are home to a vast number of companies looking to enter clini- research industry from a small cottage to a cal trials, take their compound at least through Phase II, and some are LISA HENDERSON fully-matured one has seen numerous out- fully intending to stick it through Phase III and even make it to a com- Editor-in-Chief sourcing models from the low-touch, very fo- mercial stage company.