Safety and health technological innovation Flashcards
Define
- Digital Implant
- Biohacking
Digital implant - using 3d technology to check bone conditions and nerve position
Hearing colors device
EyeBorg(POV filming experience)
Bio magnets
Microchips
Biohacking - human augmentation or human enhancement, do-it yourself
Technology aimed at improving performance, health and wellbeing.
Issues behind regulatory measures
- Lab grown meat- should not be the main source of consumption because its side effects are not fully known.
Much of the work in a laboratory, on this view, amounts to disciplining the entire cast of humans and nonhumans to function harmoniously together.
Testing and safety measures
Who? Manufacturers, citizens, legislative bodies
Question of trust and authority? - Digital implants - who is liable at the end of clinical trials? Evidence on the results of such trials should be known beforehand.
Consent is most important and consequences will be based on the agreement in the contracts.
Knowledge… What is being implanted into my body? (Consumer rights)
Consumer protection, age restrictions on certain new innovations
Patents (for innovations to get their money back→ Accessibility problems)
What are some Inappropriate decisions, even though people want them?
(Challenges: making health innovation accessible for everyone?)
When scientific claims are strong and evident → more likely to be accepted
Human preferences can have impacts on innovations e.g designer babies. There should be boundaries put in place.
Ethical concerns should be highlighted → health concerns (HIV) over aesthetically pleasing innovations like designer babies
https://www.nature.com/articles/d41586-020-00001-y → link article CRISPR-babies
Role of Society in Science
Role of Ethics in Science
What role does society have in science?
Peirce: social epistemology of science - consensual theory of truth; truth (and “the real”) depends on the agreement of the community of inquirers or that it is an effect of the real that it will in the end produce agreement among inquirers
Social-constructivism → adapting to cultural, political laws
Law has an impact on research → More law results in more funded research. Needed to ensure safety
Society sets research agenda based on needs/ priorities
What role do ethics have in science?
Scientific claims may not favor everyone → everyone has to included
Most innovations are not ethically or morally correct
Utilitarianism → Most people will benefit from the results of innovations
What is HTA?
What is Economic Evaluation?
HTA - Health technology assessment is an multi-disciplinary, scientific based assessment of technologies in healthcare that examines short- and long-term consequences of the application of a healthcare technology. The goal is to provide policymakers with information on policy alternatives.
- “HTA is a multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its lifecycle” Tummers et al.
- “HTA is used to ensure that healthcare decisions take account of relevant evidence in a systematic way” Henshall & Shuller
Economic evaluation - a branch of HTA, as for instance
social, epidemiological, organisational and
ethical/judicial social aspects. Economic evaluation
looks at the costs and effects of (new) interventions, so
weighing costs versus clinical effectiveness
What is Scarcity?
not enough resources to meet all of society’s needs or wants
Why use HTA/Economic Evaluation?
Increased spending in Western countries on health care
Budget cuts in several countries, so important question is sustainability of financing interventions
Financial barriers are increasing, for instance for reimbursement, basis package
Importance of cost-effectiveness research/economic evaluation
More interventions are developed and there is an increasing need for healthcare interventions
Rising demand for evidence based economic evaluation information
- Funding agencies (next slide)
- Health care insurance
- Ministry of Health, EU
In other words, if you are really an advocate of your intervention and want to improve sustainability always include the financial aspect evaluation
Economic Evaluation is a good one If it contains…
Comparative analysis Between 2 or more alternatives In terms of osts (INPUT) And effects (OUTPUT) 4 main designs of full/good economic evaluation: Cost minimisation analysis Cost effectiveness analysis Cost utility analysis Cost benefit analysis
What is early HTA? What are its adventages?
“all methods used to inform industry and other stakeholders about the potential value of new medical products in
development, including methods to quantify and manage uncertainty”
(IJzerman et al.)
No major difference between early HTA and traditional HTA
Early and traditional HTA → Different timing and purpose
Traditional HTA: coverage and reimbursement
Early HTA: investment and development, potential value
Measurements are still the same, evaluation along the way
(+) of early HTA
Address uncertainty
Anticipate o acceptance
Improve the efficiency of evaluation
Include different perspective from several stakeholders from the beginning
“HTA from summative to formative, and from retrospective to prospective, to guide further research and development”
Five actions for “progressive health system decision making”
Challenges of it
Five actions for “progressive health system decision making”
development of a general framework for the definition and assessment of value
disease-specific guidance
further joint scientific advice for industry on demonstrating value;
development of a framework for progressive licensing, usage, and reimbursement
promoting work to better adapt HTA, coverage, and procurement approaches to medical devices.
Challenges:
Who should be evaluating and who should be funding?
→ The International Network of Agencies for Health Technology Assessment (INHATA), 50 agencies that build a network, no overarching standard therefore mostly economists assess HTA, financial benefits should not be the only thing to value
Difficult to include patients in the development of technology
Early HTA is done in between/parallel to the development phases, HTA could slow it down or stop it
Lack knowledge in early HTA, no committees or bodies for it, recommendations don’t get implemented
Early HTA focuses a lot on the medical device itself rather than the service, fails to look at organizational or service impact, not looking at the big picture
Early HTA focuses on the development → should therefore be flexible, HTA should be performed at the earliest moment possible to see if it is actually worth it
The ones who are the fastest to develop are not always the best, get approved faster, time over quality and effectiveness, legislative problem
European Union Medical Device Regulation, need to improve how they generate evidence
→ a lot of data already gathered in the research phase, too expensive to run tests, have to get taken of the market
How does HTA determine the value of technological innovations
Make sure Decision making takes into account evidence
Aim to inform decision making
Why do we need to assess the value of health innovations?
The rapid development of new medicines, devices, procedures, and care pathways means that the range of treatment options continues to grow faster than the resources available to many patients and healthcare systems, particularly as the impacts of the global financial crisis are felt. Identifying treatment options that offer value and value for money is therefore becoming increasingly relevant.
innovation often costs a lot
Need to determine how valuable it is at different points
Efficiency and effectiveness
Do not overload the healthcare system
Depending on context → cultural differences
Need to understand the impact of innovation
How to approach the evaluation of technological health innovations
(also 4 main designs)
Wider elements of value
Core elements value
Internal (within the people who develop it, employee satisfaction) and external (customer focused) evaluation measures
Public and private evaluation measures
Promote development of frameworks and specific guidelines, progressive licensing → The evaluation of service may be external, based on a customer satisfaction survey, or internal, based on employee satisfaction.
Different stakeholders have to collaborate, joint efforts, specific and clear aim
4 main designs:
Cost minimisation analysis -> no evaluation of effectiveness
Cost effectiveness analysis -> clinical endpoints, descriptive equality of life, satisfaction
Cost utility analysis -> utilities or QALY
Cost benefit analysis ->monetary outcome
Multi Criteria Decision Analysis (MCDA) → mathematically combine, take more than one measure into account
Efficiency is quite vague → be careful what you actually want to measure
When and how is it decided that a health technology is publicly funded
If a new innovation can substitute an older one it gets exchanged → how much better does it have to be to substitute it?
First determine value, significant difference in value looking from the public perspective
Paradox: new innovation might be less effective and cost the healthcare system more
Who or which values should we consider (value based decision making)
(Perspectives)
Patients Perspective: improvement in the length and/or quality of life
General Public/Societal Perspective: Maximizing the “public good”
Health System Perspective: resource limited system, allocate resources to care of proven value
Industry Perspective: aim is profit, patient and technological advances as a mean to an end, depend on demand
Core element of value Health benefits for the patient: Improved prognosis/survival Symptom/pain relief Improved functioning Reduction in unwanted effects, or reduced risk of adverse events, or improved benefit/risk ratio.
Organization Perspective:
provide funding
expert knowledge
Public and Private Sector: nature and product of services differs, different priorities
Public is a multidimensional complex construct, meet the needs of people, ensure safety and trust
development of a general framework for the assessment of value by HTA bodies
development of disease-specific guidance for industry from regulators and HTA bodies
develop joint scientific advice for industry
development of a framework for progressive licensing, usage, and reimbursement
stakeholders defined as “actors directly involved in the decision making process and actors who are, or might be, affected by any action taken by an organization or group” . These may be patients, clinicians, the innovation developer, other professionals involved
in the care situation, parties representing the taxpayer
It is generally recognized that stakeholder involvement is crucial to support the development of technologies that will
be accepted and used in practice
The goal of stakeholder involvement is to optimize the validity, acceptability and legitimacy of both the innovation and its assessment as much as possible → the strengthening of health economic modeling with stakeholder involvement promises to improve the quality and relevance of early assessments.
