Data Governance for Real-World Evidence: Cross-country differences and recommendations for a governance framework
Cole, A., Garrison, L., Mestre-Ferrandiz, J. & Towse A.
Are Wider Societal Effects Considered in Healthcare Decision-making? An over...Office of Health Economics
Presentation at ISPOR Italy - 12.04.16 - Are Wider Societal Effects Considered in Healthcare Decision-making? An overview from other countries by Martina Garau, OHE
Presentation on the literature review of interventions to improve health care...IDS
This presentation was given in a Future Health System Consortium organised session at the Global Symposium on Health Systems Research in November 2010. The author is Alex Rowe from the Centers for Disease Control and Prevention.
Analysis of cross-country changes in health services IDS
This presentation was given in a session at the Global Symposium on Health Systems Research which was organised by the Future Health Systems Consortium. The author is Toru Matsubayashi from Johns Hopkins Bloomberg School of Public Health
Health Technology Assessment (HTA) Report: Interventions to increase particip...HTAi Bilbao 2012
Health Technology Assessment (HTA) Report: Interventions to increase participation to organised cancer screening programs
Ministry of Health Grant for Applied Research
Giorgi Rossi P, Camilloni L, Ferroni E, Jimenez B, Furnari G, Guasticchi G, Borgia P.
Laziosanità – Agenzia di Sanità Pubblica della Regione Lazio
Evidence on Improving Health Service Delivery in Developing CountriesIDS
This presentation by David Peters of the Future Health Systems Consortium was given at the Global Symposium on Health Systems Research in November 2010.
Are Wider Societal Effects Considered in Healthcare Decision-making? An over...Office of Health Economics
Presentation at ISPOR Italy - 12.04.16 - Are Wider Societal Effects Considered in Healthcare Decision-making? An overview from other countries by Martina Garau, OHE
Presentation on the literature review of interventions to improve health care...IDS
This presentation was given in a Future Health System Consortium organised session at the Global Symposium on Health Systems Research in November 2010. The author is Alex Rowe from the Centers for Disease Control and Prevention.
Analysis of cross-country changes in health services IDS
This presentation was given in a session at the Global Symposium on Health Systems Research which was organised by the Future Health Systems Consortium. The author is Toru Matsubayashi from Johns Hopkins Bloomberg School of Public Health
Health Technology Assessment (HTA) Report: Interventions to increase particip...HTAi Bilbao 2012
Health Technology Assessment (HTA) Report: Interventions to increase participation to organised cancer screening programs
Ministry of Health Grant for Applied Research
Giorgi Rossi P, Camilloni L, Ferroni E, Jimenez B, Furnari G, Guasticchi G, Borgia P.
Laziosanità – Agenzia di Sanità Pubblica della Regione Lazio
Evidence on Improving Health Service Delivery in Developing CountriesIDS
This presentation by David Peters of the Future Health Systems Consortium was given at the Global Symposium on Health Systems Research in November 2010.
Reflections on Implementing Value-based Assessment in the UK -- Towse at HESG Office of Health Economics
Value-based pricing, as originally proposed in the UK, was intended to achieve several objectives, including broadening the definition of value. This presentation reviews important issues in defining value, demonstrates how past policy aimed at value has affected the availability of some medicines, and suggests ways forward under the revised, value-based assessment approach.
> HTA and Real World Evidence (RWE)
> Why RWE? - Limitations with RCT
> RCT v/s RWE
> Definition of RWE
> Sources of RWE
> Advantages of RWE
> Application of Real World Data (RWD) in RWE
> Benefits of RWD in RWE
> Why Data Sharing is Important?
> Important Stakeholders
> How to Encourage Data Sharing?
> Benefits of Data Sharing
> Case Studies
> Data Privacy Scenario
> Data Security in India
> Regulatory Perspectives Around RWD/RWE
> Way Forward
The role of real world data and evidence in building a sustainable & efficien...Office of Health Economics
This presentation defines RWD and RWE in the context of digital health, and looks at potential uses for RWD and RWE. It briefly sets out the current landscape in Malaysia and looks at the challenges in using RWE. In particular, the issues of access, governance and ensuring good quality are considered.
A hybrid approach to data management is emerging in healthcare as organizations recognize the value of an enterprise data warehouse in combination with a data lake.
In this SlideShare, we discuss data lakes in healthcare and we:
Provide an overview of a Hadoop-based data lake architecture and integration platform, and its application in machine learning, predictive modeling, and data discovery
Discuss several key use cases driving the adoption of data lakes for both providers and health plans
Discuss available data storage forms and the required tools for a data lake environment
Detail best practices for conducting data lake assessments and review key implementation considerations for healthcare
Health Information Exchange ( usage and benefits )Htun Teza
Presentation for RADS 601 ( Health Informatics and Health Information Technology ) - 20/11/19
Student of Master of Science in Data Science for Healthcare ( International Program ) ( Clinical Epidemiology and Biostatistics, Mahidol University, Thailand )
Integrate RWE into clinical developmentIMSHealthRWES
With greater application of RWE throughout the pharmaceutical
lifecycle, learnings are emerging that offer guidance for
approaches to derive the maximum value. This article captures
the author’s experience at a leading international biotech, with
insights for smoothing RWE assimilation into clinical
development and realizing the benefits it brings.
Exploring the Use of Real-World Evidence in Health Technology Assessment (HTA)ClinosolIndia
Real-world evidence (RWE) refers to data obtained from real-world settings, such as electronic health records, claims databases, wearable devices, and patient registries. Health Technology Assessment (HTA) is a systematic evaluation of the clinical, economic, and social impacts of healthcare technologies. The use of real-world evidence in HTA is gaining traction as a valuable complement to traditional randomized controlled trials (RCTs) and can provide additional insights into the effectiveness, safety, and value of healthcare interventions. Here are some key points exploring the use of real-world evidence in HTA
Real-World Evidence Studies_ Introduction, Purpose, and Data Collection Strat...ProRelix Research
The first image that comes to mind when one thinks of where safety and
efficacy data for a new treatment is generated is a randomized controlled
trial (RCT) at a central site. Although RCTs remain the gold standard for
evidence generation of new treatments, they are limited in terms of their
applicability to broader patient populations with different demographics
such as age, ethnicity, and comorbidities thus limiting their
generalizability. RCTs are carried out under strict conditions and dosing
schedules which are often not observed in the real world and are
conducted for limited time periods which are usually not sufficient to
capture adverse events, especially in the case of chronic diseases. This
has led to a shift in the thinking of sponsors, drug developers, payers,
and regulators to consider the use of real-world data and
real-world-evidence studies to inform decisions related to the product as
well as to support reimbursement decisions.Real-world evidence (RWE) is the clinical evidence regarding the usage
and potential benefits or risks of a medicinal product obtained from
real-world data (RWD). RWD is regarded as observational data that is
collected outside of a traditional RCT (1). Although the terms RWD and
RWE are used interchangeably they are two distinct concepts. Not all
RWD translates into RWE. RWE is obtained by detailed analyses of data
from different types of trials such as pragmatic trials, observational
studies which can be prospective or retrospective, late-phase trials, or
hybrid trials which are designed to collect data from patients in a
real-world setting. The data that is collected can be in various forms such
as electronic health records (EHRS), claims and billing data, product and
disease registries, prescription data, data collected from routine hospital
and physician visits, patient-reported outcomes (PROs), and mobile and
wearable devices. Recently, data from biobanks and ‘-omics’ data is
becoming a valuable source of RWD. RWE studies are intended to
complement data generated from RCTs by providing a detailed view of
the actual use of the product and effectiveness and safety data that RCTs
are unable to capture.There has been a recent upward trend in the number of RWE trials
conducted. In 2021, the Global Data Clinical Trials Database recorded
194 RWE trials and the Food and Drug Administration (FDA) published
90 examples of the use of RWE to support regulatory decisions (2). Since
2018, the FDA has released several pieces of guidance to support the
use of RWD and RWE for regulatory decision-making for drugs and
medical devices and the type of data to be submitted to support these
applications. The two main drivers for recent interest and uptake of RWE
studies are:
A Standards-based Approach to Development of Clinical Registries - Initial Le...Koray Atalag
This is the prezo I presented at HINZ 2014 conference.
Gestational diabetes has implications for both mother and child with risk of complications during pregnancy, and type 2 diabetes later in life. This paper presents the initial lessons learned from the development of a clinical registry. The aims of the Registry are: 1) 100% successful diabetes screening within 3 months of delivery; 2) Annual type 2 diabetes screening; 3) Early warning in subsequent pregnancies.
We have employed the openEHR standard which underpins our national interoperability reference architecture to represent the dataset and also to build the web-based registry system. Use of this rigorous methodology to tackle health information is expected to ensure semantic consistency of Registry data and maximise interoperability with other Sector projects. The development work has been facilitated by the ability to transform the dataset automatically into software code – ensuring clinical requirements accurately translated into technical terms.
Dataset has been finalised, registry system has been developed and deployed for pilot implementation. Data entry is underway for participants after consenting.
This registry is expected to increase the screening of women leading to earlier detection of diabetes. It should provide a valuable picture of the condition and is intended for extension and wider roll-out after evaluation.
SNOMED by Professor Martin Severs FRCP FFPHM Chairman Management Board.
There is a media intensive (22MB) version of this presentation with an audio track and video at:
http://hinz.org.nz/media/SNOMED-ProfSevers/
Disclaimer: Huge + You may have to hit refresh a couple of times to get it to load correctly.
Browne Jacobson, Deloitte and DoctorLink are pleased to invite you to our first joint health tech seminar with leading industry thought leaders. This will be a practical session, sharing experience from across the NHS and beyond to inform options on how to improve services, break down silos and focus on population health outcomes.
This event is exclusively for Commissioners, GPs, and Policymakers keen to understand how new integrated care systems and models of care can meet the needs of their local population and can be implemented pragmatically and affordably to drive improvement goals and achieve better health, better care and better value.
> Definition of RWD
> RWD - Big Data Characteristics
> Sources of RWD
> Important Stakeholders
> Benefits of RWD
> Why Data Sharing is Important?
> Benefits of Data Sharing
> Who Benefits?
> Ultimate Goals
> Case Studies
> Challenges
> Data Privacy Scenario
> Data Security in India
> Regulatory Perspectives Around RWD
> How to Encourage Data Sharing?
The Impact of Real-World Data in Pharmacovigilance and Regulatory Decision-Ma...ClinosolIndia
Real-world data (RWD) has gained significant importance in pharmacovigilance and regulatory decision-making processes. Real-world data refers to data collected from routine clinical practice, including electronic health records (EHRs), claims databases, registries, and other sources, outside the controlled environment of clinical trials. Here are some key impacts of real-world data in pharmacovigilance and regulatory decision-making
Data Standards and Interoperability in Clinical Research and Data ManagementClinosolIndia
Data standards and interoperability play a crucial role in clinical research and data management. They ensure that data collected from various sources can be effectively shared, integrated, and analyzed across different systems and organizations. Here's an overview of data standards and interoperability in the context of clinical research and data management
The role of the FAIR Guiding Principles in a Learning Health SystemMichel Dumontier
The learning health system (LHS) is a concept for a socio-technological system that continuously improves the delivery of health care by coupling biomedical research with practice- and evidence- based medicine. Key aspects of the LHS are collecting, integrating, and analyzing data from different sources. While the increased digitalisation of healthcare is creating new data sources, these remain hard to find and use, let alone make use of as part of intelligent systems for the benefit of patients, healthcare providers, and researchers. This talk will examine recent developments towards making key parts of the LHS, such as clinical practice guidelines, Findable, Accessible, Interoperable, and Reusable (FAIR).
On 31 October 2019, Adrian Towse and Chris Henshall from the Office of Health Economics (OHE) presented at the G20 meeting on antimicrobial drugs R&D in Paris organised by the Wellcome Trust. The topic of their presentation was HTA and payment mechanisms for new drugs to tackle antimicrobial resistance.
This presentation looks at ways in which governments can set prices, including “cost plus”, value, and the external referencing of prices elsewhere. It looks at the role that competition can play in keeping down prices. In that context it briefly discusses pricing proposals being considered in Malaysia. It makes the case for using HTA to inform pricing decisions.
Adrian Towse
% GDP spending in UK, G5 countries and OECD upper middle income countries. W...Office of Health Economics
This presentation looks at rates of GDP spend on health care, distinguishing between categories of country (i.e. levels of GDP pre capita). It looks at the relationship between rates of spending and moves to universal health coverage, and explores alternative ways of increasing expenditure and making decisions about which services to provide with the money available.
The aim of this educational symposium was to discuss why we should seek value across the health care system and how we can apply existing research methods to measure the value of services. While considerable political attention in developed countries continues to be focused on drug spending, there is also growing awareness of the significant contribution of non-drug components of health care (e.g., hospital services and inefficient care delivery) to overall spending growth and patient affordability. At the same time, there is growing interest in making greater use of value assessment and value-based payment to control spending and better align it with care quality. In order to promote greater value, and to do so in ways that respond to the needs of payers and patients, it is essential to assess value across both drug- and non-drug interventions and health care services. This panel will offer expert viewpoints to identify and discuss gaps in value information, rationale and approaches to track and reduce system-wide low value care, and research methods for how to measure health care services.
Role Substitution, Skill Mix, and Provider Efficiency and Effectiveness : Les...Office of Health Economics
Graham participated in an organised session on Monday July 15th 2019. In the session he presented his paper with his co-author Ioannis Laliotis from the London School of Economics. The paper revisits the relationship between workforce and maternity outcomes in the English NHS in an attempt to contribute knowledge to an important policy question for which there has been a paucity of research.
This research explores the feasibility of introducing an Outcome-Based Payment approach for new cancer drugs in England. A literature review explored the current funding landscape in England, the available evidence on existing OBP schemes internationally, and
which outcomes cancer patients value most. Two focus groups and an online survey with patients and carers, as well as interviews with NHS and government stakeholders, healthcare
professionals, and pharmaceutical industry representatives, provided additional evidence on the feasibility and suitability of OBP schemes
Understanding what aspects of health and quality of life are important to peopleOffice of Health Economics
Poster presentation from the EuroQol Plenary Meeting 2019, Brussels, Belgium. By Koonal Shah, Brendan Mulhern, Patricia Cubi-Molla, Bas Janssen, and David Mott.
Koonal presented as part of an organised session on ‘moving beyond conventional economic approaches in palliative and end of life care’. He summarised the empirical evidence on the extent of pubic support for an end of life premium, before discussing some novel approaches that have been used in recent studies. His presentation was discussed by Helen Mason of Glasgow Caledonian University.
Author(s) and affiliation(s): Koonal Shah, Office of Health Economics
Event: iHEA Congress
Date: 17/07/2019
Location: Basel, Switzerland
Assessing the Life-Cycle Value Added of Second Generation Antipsychotics in S...Office of Health Economics
This research presented in a poster at HTAi 2019, Cologne (Germany) by a team of OHE and IHE researchers, estimates the value added by second generation antipsychotics over their life-cycle in the UK and Sweden. It concludes that considering the entire life-cycle, the value added by SGAs to the system is higher than the expected value estimated at launch. P&R decisions should consider how to measure, capture and take into account the value added by medicines over the long-run.
Author(s) and affiliation(s): Mikel Berdud (Office of Health Economics, London), Niklas Wallin-Bernhardsson (Institute for Health Economics, Stockholm), Bernarda Zamora (Office of Health Economics, London), Peter Lindgren (Institute for Health Economics, Stockholm), Adrian Towse (Office of Health Economics, London)
Event: HTAi 2019 Annual Meeting
Date: 18/06/2019
Location: Cologne, Germany
There is growing recognition that HTA and contracting systems for antimicrobials need to be adapted to help fight the threat of antimicrobial resistance (AMR), but there is little agreement on how. This poster reports findings from a literature review, expert interviews and face-to-face discussions at a Forum on the current HTA and payment systems for antibiotics across Europe and a number of recommendations for adapting these systems to respond to the challenges of AMR.
Author(s) and affiliation(s): Margherita Neri (OHE) Grace Hampson (OHE) Christopher Henshall (OHE visiting fellow, independent consultant) Adrian Towse (OHE)
Event: HTAi annual conference 2019
Date: 18/06/2019
Location: Cologne, Germany
Assessing the Life-cycle Value Added of Second-Generation Antipsychotics in S...Office of Health Economics
This study aims to guide access decisions and drive the discussion on access and price, through recognition of the dynamic nature of value added by pharmaceutical innovation over the long-run. The analysis of the life-cycle value of risperidone estimates the value generated in the UK and Sweden. Results show that health systems were able to appropriate most of the life-cycle value generated, and this is larger than estimated at launch.
Author(s) and affiliation(s): Mikel Berdud(1), Niklas Wallin-Bernhardsson(2), Bernarda Zamora(1), Peter Lindgren(2), and Adrian Towse(1) (1) Office of Health Economics (2) The Swedish Institute for. Health Economics
Event: XXXIX JORNADAS DE ECONOMÍA DE LA SALUD
Date: 12/06/2019
Location: Albacete, Spain
Prescribed Specialised Services (PSS) Commissioning for Quality and Innovation (CQUIN) schemes were launched in 2013 in England with the aim of improving the quality of specialised care and achieving value for money. During this presentation, Marina Rodes Sanchez described the key features of the schemes and discussed its strengths and weaknesses based on international pay-for-performance literature.
Author(s) and affiliation(s): Yan Feng, Queen Mary University of London; Søren Rud Kristensen, Imperial College London; Paula Lorgelly, King’s College London; Rachel Meacock, University of Manchester; Marina Rodes Sanchez, Office of Health Economics; Luigi Siciliani, University of York; Matt Sutton, University of Manchester
Event: XXXIX Spanish Health Economics Association Conference
Date: 12/06/2019
Location: Albacete, Spain
In this session, Meng Li sets out estimates of real option value for drugs arguing that option value matters and can be calculated. Adrian Towse sets out likely payer concerns about incorporating real option value into decision making. Meng Li responds to these concerns. Jens Grueger sets out how industry considers investment opportunities, arguing that if patients (and society) have preferences these need to be reflected in P&R decisions.
Author(s) and affiliation(s): Meng Li, Postdoctoral Research Fellow, Leonard D Schaeffer Center, University of Southern California, Los Angeles, CA, USA. Adrian Towse, Emeritus Director, Office of Health Economics, London, UK Jens Grueger, formerly Head of Global Access, Senior Vice President at F. Hoffmann-La Roche
Event: ISPOR 2019
Location: New Orleans, USA
Date: 21/05/2019
MCDA OR WEIGHTED CEA BASED ON THE QALY? WHICH IS THE FUTURE FOR HTA DECISION ...Office of Health Economics
In this ISPOR session Chuck Phelps and Adrian Towse debated the case for and against using MCDA to support HTA decision making, as compared to weighting or augmenting a QALY based ICER approach. Chuck Phelps argued for use of MCDA, Adrian Towse for weighting the QALY. Nancy Devlin set the scene and moderated.
Author(s) and affiliation(s): Nancy Devlin, Director, Centre for Health Policy, University of Melbourne, Australia Adrian Towse, Emeritus Director, Office of Health Economics, London, UK Chuck Phelps, University of Rochester, Rochester, NY USA
Event: ISPOR 2019
Location: New Orleans, USA
Date: 21/05/2019
The issue of open-source models in the cost-effectiveness and disease-level (collaborative) models has been brewing for many years. There has been a marked growth in open science, and funding bodies and publishers increasingly require that research data be made available. As mentioned in our previous Issue Panel, “cost-effectiveness models synthesise a wide range of evidence to facilitate extrapolation over time and from intermediate to final decision endpoints. These models are often statistically sophisticated and require assumptions that are not directly testable. This can lead to decision-makers “discounting” the results of cost-effectiveness analyses, particularly if the developer is seen as partial.” Open-source models, then, would encourage greater transparency in pharmacoeconomic modeling and the reuse and updating of the best/most useful models; they are essential if cost-effectiveness analyses are to be widely accepted to reduce bias, increase transparency, improve model access, and allow for faster access to critical knowledge. The ISPOR-SMDM guidelines and the EUnetHTA joint action projects, are supportive of these views on collaboration, transparency, confidentiality, processes and consistency offered by the availability of open-source models to improve decision-making around health care and reimbursement. With openness and sharing, however, come issues of copyright and access and a need to define how model sharing can be achieved in a fair and equitable manner. There is, therefore, a need to develop an ongoing dialog on openness, especially where the research may be considered precompetitive and not worthy of IP investment. The pros and cons of open source models and the proposed mission of the Open Source Model SIG to curate an ongoing dialog regarding issues around creating, disseminating, sharing, evaluating, and updating open source cost-effectiveness and comparative effectiveness models will be debated amongst SIG members.
Author(s) and affiliation(s): Nancy Risebrough, Senior Principal, ICON plc, Toronto, Canada Jeroen P Jansen; Innovation & Value Initiative; Precision Medicine Group; and Stanford University Lotte Steuten, Vice President & Head of Consulting, Office of Health Economics, UK Renée JG Arnold, PharmD, RPh, ICON plc, New York, NY and Icahn School of Medicine at Mount Sinai, New York, NY, USA
Event: ISPOR 2019 Annual Meeting
Date: 20/05/2019
This presentation by Morris Kleiner (University of Minnesota), was made during the discussion “Competition and Regulation in Professions and Occupations” held at the Working Party No. 2 on Competition and Regulation on 10 June 2024. More papers and presentations on the topic can be found out at oe.cd/crps.
This presentation was uploaded with the author’s consent.
Acorn Recovery: Restore IT infra within minutesIP ServerOne
Introducing Acorn Recovery as a Service, a simple, fast, and secure managed disaster recovery (DRaaS) by IP ServerOne. A DR solution that helps restore your IT infra within minutes.
Sharpen existing tools or get a new toolbox? Contemporary cluster initiatives...Orkestra
UIIN Conference, Madrid, 27-29 May 2024
James Wilson, Orkestra and Deusto Business School
Emily Wise, Lund University
Madeline Smith, The Glasgow School of Art
Have you ever wondered how search works while visiting an e-commerce site, internal website, or searching through other types of online resources? Look no further than this informative session on the ways that taxonomies help end-users navigate the internet! Hear from taxonomists and other information professionals who have first-hand experience creating and working with taxonomies that aid in navigation, search, and discovery across a range of disciplines.
0x01 - Newton's Third Law: Static vs. Dynamic AbusersOWASP Beja
f you offer a service on the web, odds are that someone will abuse it. Be it an API, a SaaS, a PaaS, or even a static website, someone somewhere will try to figure out a way to use it to their own needs. In this talk we'll compare measures that are effective against static attackers and how to battle a dynamic attacker who adapts to your counter-measures.
About the Speaker
===============
Diogo Sousa, Engineering Manager @ Canonical
An opinionated individual with an interest in cryptography and its intersection with secure software development.
0x01 - Newton's Third Law: Static vs. Dynamic Abusers
OHE RWE Poster - HTAi Tokyo May 2016
1. Data Governance for Real-World Evidence:
Cross-country differences and
recommendations for a governance framework
Cole, A.1, Garrison, L.2, Mestre-Ferrandiz, J.1 & Towse A.1
Contact: acole@ohe.org 1Office of Health Economics, 2Universtiy of Washington
1. BACKGROUND
Real-world data (RWD) is information that can be used for
health care decision-making which is collected outside of an
experimental clinical trial setting. RWD is becoming
increasingly important to:
• Reflect outcomes in routine clinical practice
• Meet the needs of regulators and payers, who are being
challenged to conduct earlier assessments under greater
uncertainty, and monitoring outcomes throughout a
product’s lifecycle
RWD becomes real-world evidence (RWE) – what is really
of value to stakeholders – after a series of activities which
facilitate the transformation of raw data into analysis and
results. Robust and proportionate data governance, applied at
each step, is essential in realising the value of RWD and its
derivative RWE.
Acknowledgements
This research was funded and initiated by Eli Lilly and Company
2. AIMS
• To analyse the core governance arrangements for how RWD is
accessed or generated, and used credibly to provide evidence,
in eight countries.
• To propose an aspirational governance framework.
3. METHODS
• Investigate the governance arrangements in place in the UK,
France, Italy, Sweden, Germany, Netherlands, Australia, and
the U.S.
• Use a structured pro-forma to assess core legislation for the
collection and use of (both routinely-collected and de novo)
data, data linkage opportunities, the data access environment,
data use, and imminent changes to this landscape.
• Identify strengths and weaknesses in the current international
approaches to data governance.
4.RESULTS
In order to utilise and derive value from RWD, appropriate and
facilitative information governance is essential, thus transforming
RWD into RWE.
5. DISCUSSION
• Difficulties arise because RWD is
being used for purposes beyond
those for which it was originally
collected: to directly manage
patient care.
• Legal frameworks are playing
catch-up to accommodate these
new secondary uses of data,
which also benefit patients and
society, but in a different way.
• By describing the process by which RWD (the raw data) is
transformed into RWE (the insight), and assessing the rules
and roles for information governance along this process in
eight countries, we set out a framework for good governance
which supports a favourable environment for RWE
development and use.
• Countries have different approaches for achieving the balance
between protecting privacy and supporting research that is in
the public’s interest. In most cases the legal framework is not
completely prescriptive, making a clear governance framework
essential.
• Appropriate and facilitative governance arrangements for RWE
are imperative to facilitate evidence collection to meet the
demands of regulators and HTA bodies, and to make the most
of health care information and the role it can play in improving
patient care.
Privacy
interest
Public
interest
Recommendations for an ideal governance framework include:
• Data protection legislation. There must be clear protection
requirements that recognise the legitimacy of health care data
utilisation beyond the direct care of patients.
• Patient consent has a central role; where data collection is
on a routine basis across a large patient cohort, an opt-out
system of consent may be appropriate.
• There should be transparent mechanisms for data linkage
which employ pseudonymisation tools to protect anonymity but
maintain data integrity. For datasets to be compatible there
needs to be a clear set of nationally agreed standards to
optimise interoperability of health record systems.
UK US France Italy
Sweden Germany Netherlands Australia
We developed and outlined 29 elements of an ideal governance
framework, and considered all countries against each criteria
Aligned with recommendation
Aspect addressed but room for
improvement
Barrier or very problematic
Insufficient information to make
a judgement
Current governance arrangements compare variably against our
recommendations. For example, in Italy data collection is strong
but access is poor. National data linkage networks, such as that
established in Australia, offer huge potential. However,
transparency is essential: UK and Netherlands provide examples
of public trust breaking down, thus impeding RWD programmes.
Sweden and the U.S. perform well across our proposed
framework; Germany and France are more restrictive.
• Data access arrangements should be based on careful
consideration of the motivation for and outputs of the
research facilitated, rather than on the basis of the
organisation’s status. Authorisation should be granted by
approval panels which assess risks and benefits,
implementing data use agreements as necessary.
6. CONCLUSION
• The core objective is to balance public and privacy interests:
to advance our understanding of medical treatments through
evaluation and research, on the one hand, and protect
individuals’ privacy, on the other.