Against black box medicine

Explainable machine learning practices: opening another black box for reliable medical AI 

In regulating medical AI, we should address not only algorithmic opacity, but also on other black boxes plaguing these tools. In particular, there are many opaque choices that are made in the training process and in the way algorithmic systems are built, which can potentially impact SaMD-MLs performances, and hence their reliability. Second, we have said that opening this alternative black box means explaining the training process. This type of explanation is in part documenting the technical choices made from problem selection to model deployment, but it is also motivating those choices by being transparent about the values shaping the choices themselves—in particular, performance-centered values and ethical/social/political values. Overall, our framework can be considered as a starting point to investigate which aspects of the design of AI tools should be made explicit in medicine, in order to inform discussions on the characteristics of reliable AI tools, and how we should regulate them. We have also highlighted some limitations, and we have claimed that in the future it will be necessary to empirically investigate the practice of machine learning in light of our framework, and to identify more nuances in the values shaping ML training.

We want to end this article by repeating that the problem of explaining opaque technical choices is not an alternative to explain the opacity lying at the algorithmic level. Unlike London, we think that the worries about algorithmic opacity in medicine are more than justified. However, we leave any consideration on how the two opacities are connected to each other for future works.

Huge business interests are at  stake, who cares about citizens?

Didier Lourenço at Galeria Barnadas

AI everywhere (12)

 Artificial Intelligence-based software as a medical device

Sedentarism, a disease from XXI century

 Guia de prescripció d’exercici físic per a la salut

A call for a new skill mix in health professions

Skill-mix Innovation, Effectiveness and Implementation. Improving Primary and Chronic Care

Reforming healthcare

 A New Health and Care System: Escaping the Invisible Asylum

Drug scarcity

Shortages of medicines in OECD countries

Even in wealthy economies, access to medicines is increasingly affected by medicine shortages – an issue exacerbated with the onset of the COVID-19 pandemic. The aim of this paper was to examine the extent and nature of medicine shortages in OECD countries (pre-COVID-19) and explore the reasons for this growing global problem. Although differences in monitoring mechanisms make multi-country analyses challenging, a sample of 14 OECD countries reported a 60% increase in the number of shortage notifications over the period 2017-2019. While the complexity of pharmaceutical manufacturing and supply chains hampers root cause analyses, available literature suggests that shortages, as reported by marketing authorisation holders, are predominantly due to manufacturing and quality issues. Nevertheless, commercial factors - and the policy settings that influence them - may play an important role. Although several OECD countries have implemented policy measures to mitigate, monitor and prevent shortages, more robust data and further analyses of root causes and effective policy responses are needed. The way forward should involve a global approach that engages all relevant actors and looks beyond the health care sector alone.

 

Obamacare, before and after its implementation

The Trillion Dollar Revolution, How the Affordable Care Act Transformed Politics, Law, and Health Care in America

 Reinventing American Health Care.. How the Affordable Care Act will Improve our Terribly Complex, Blatantly Unjust, Outrageously Expensive, Grossly Inefficient, Error Prone System

Platforms, a business model (6)

 Advanced Introduction to Platform Economics

Attacking health care

PERILOUS MEDICINE.  The Struggle to Protect Health Care from the Violence of War

As a member of the Scientific Committee of Healing across the divides, please let me suggest this book by Leonard Rubinstein

Pervasive violence against hospitals, patients, doctors, and other health workers has become a horrifically common feature of modern war. These relentless attacks destroy lives and the capacity of health systems to tend to those in need. Inaction to stop this violence undermines long-standing values and laws designed to ensure that sick and wounded people receive care.

Leonard Rubenstein—a human rights lawyer who has investigated atrocities against health workers around the world—offers a gripping and powerful account of the dangers health workers face during conflict and the legal, political, and moral struggle to protect them. In a dozen case studies, he shares the stories of people who have been attacked while seeking to serve patients under dire circumstances including health workers hiding from soldiers in the forests of eastern Myanmar as they seek to serve oppressed ethnic communities, surgeons in Syria operating as their hospitals are bombed, and Afghan hospital staff attacked by the Taliban as well as government and foreign forces. Rubenstein reveals how political and military leaders evade their legal obligations to protect health care in war, punish doctors and nurses for adhering to their responsibilities to provide care to all in need, and fail to hold perpetrators to account.

Bringing together extensive research, firsthand experience, and compelling personal stories, Perilous Medicine also offers a path forward, detailing the lessons the international community needs to learn to protect people already suffering in war and those on the front lines of health care in conflict-ridden places around the world.

 

AI everywhere (12)

 The Tyranny of Algorithms: Freedom, Democracy, and the Challenge of AI

Alternative payment models for pharmaceuticals

Outcomes-based reimbursement for gene therapies in practice: the experience of recently launched CAR-T cell therapies in major European countries

Kymriah® and Yescarta® have relatively uniform list prices across the EU5, and are reimbursed according to their marketing authorisations. In France and the UK, reimbursement is on the condition of collecting additional data (at the cohort level) and subject to future reassessments; elsewhere, rebates (Germany) or staged payments (Italy and Spain) are linked to individual patient outcomes.

 Kymriah® and Yescarta® were two of the subject therapies used to pilot and validate the Valtermed system for roll-out in November. Kymriah® is reimbursed in the Spanish NHS through two outcomesbased, staged payments based on data collected through the Valtermed system: one at the time of treatment (reported to be 52% of the total €320,000 ), and a second payment at 18 months (reportedly the remaining 48%), provided that the patient has achieved and sustained a complete response to the treatment. Yescarta® was approved for reimbursement in July 2019, and follows a similar approach to Kymriah®, however, with payments linked to survival as collected through Valtermed: reportedly a first payment of €118,000, and a second payment of €209,000

 Adolf Mas (1907) exhibition at KBR

Free our genes (3)

 Patents on Life. Religious, Moral, and Social Justice Aspects of Biotechnology and Intellectual Property

Against patents, again (2)

 Patents, Human Rights, and Access to Medicines

Knowledge and decisions as the engine of health reform

 Better Doctors, Better Patients, Better Decisions: Envisioning Health Care 2020