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WHO’s first global report on AI in healthcare includes guiding principles

Artificial Intelligence (AI) holds great promise for improving the delivery of healthcare and medicine worldwide, but only if ethics and human rights are put at the heart of its design, deployment, and use, according to new WHO guidance published June 28.

The report, Ethics and governance of artificial intelligence for health[1], is the result of two years of consultations held by a panel of international experts appointed by WHO.

“Like all new technology, artificial intelligence holds enormous potential for improving the health of millions of people around the world, but like all technology it can also be misused and cause harm,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “This important new report provides a valuable guide for countries on how to maximize the benefits of AI, while minimizing its risks and avoiding its pitfalls.”

Artificial intelligence can be, and in some wealthy countries is already being used to improve the speed and accuracy of diagnosis and screening for diseases; to assist with clinical care; strengthen health research and drug development, and sup- port diverse public health interventions, such as disease surveillance, outbreak response, and health systems management.

AI could also empower patients to take greater control of their own health care and better understand their evolving needs. It could also enable resource-poor countries and rural communities, where patients often have restricted access to healthcare workers or medical professionals, to bridge gaps in access to health
services.

However, WHO’s new report cautions against overestimating the benefits of AI for health, especially when this occurs at the expense of core investments and strategies required to achieve universal health coverage.

It also points out that opportunities are linked to challenges and risks, including unethical collection and use of health data; biases encoded in algorithms, and risks of AI to patient safety, cybersecurity, and the environment.

For example, while private and public sector investment in the development and deployment of AI is critical, the unregulated use of AI could subordinate the rights and interests of patients and communities to the powerful commercial interests of technology companies or the interests of governments in surveillance and social control.

The report also emphasizes that systems trained primarily on data collected from individuals in high-income countries may not perform well for individuals in low-and middle-income settings.

AI systems should therefore be carefully designed to reflect the diversity of socio-economic and healthcare settings. They should be accompanied by training in digital skills, community engagement and awareness- raising, especially for millions of healthcare workers who will require digital literacy or retraining if their roles and functions are automated, and who must contend with machines that could challenge the decision-making and autonomy of providers and patients.

Ultimately, guided by existing laws and human rights obligations, and new laws and policies that enshrine ethical principles, governments, providers, and designers must work together to address ethics and human rights concerns at every stage of an AI technology’s design, development, and deployment.

To limit the risks and maximize the opportunities intrinsic to the use of AI for health, WHO provides the following principles as the basis for AI regulation and governance:

  1. Protecting human autonomy: In the context of health care, this means that humans should remain in control of health-care systems and medical decisions; privacy and confidentiality should be protected, and patients must give valid informed consent through appropriate le- gal frameworks for data protection.
  2. Promoting human well-being and safety and the public interest. The de- signers of AI technologies should satisfy regulatory requirements for safety, accuracy and efficacy for well-defined use cases or indications. Measures of quality control in practice and quality improvement in the use of AI must be available.
  1. Ensuring transparency, explainability and intelligibility. Transparency requires that sufficient information be published or documented before the design or deployment of an AI technology. Such information must be easily accessible and facilitate meaningful public consultation and debate on how the technology is designed and how it should or should not be used.
  2. Fostering responsibility and ac- countability. Although AI technologies perform specific tasks, it is the responsibility of stakeholders to ensure that they are used under appropriate conditions and by appropriately trained people. Effective mechanisms should be available for questioning and for redress for individuals and groups that are adversely affected by decisions based on algorithms.
  3. Ensuring inclusiveness and equity. Inclusiveness requires that AI for health be designed to encourage the widest possible equitable use and access, irrespective of age, sex, gender, income, race, ethnicity, sexual orientation, ability or other characteristics protected under human rights codes.
  4. Promoting AI that is responsive and sustainable. Designers, developers and users should continuously and transparently assess AI applications during actual use to determine whether AI responds adequately and appropriately to expectations and requirements. AI systems should also be designed to minimize their environmental consequences and increase energy efficiency. Governments and companies should address anticipated disruptions in the workplace, including training for health-care workers to adapt to the use of AI systems, and potential job losses due to use of automated systems.

References
[1] WHO: Ethics and governance of artificial intelligence for health
https://www.who.int/publications/i/item/9789240029200


Caesarean section rates continue to rise globally

According to new research[1] from the World Health Organization (WHO), caesarean section use continues to rise globally, now accounting for more than 1 in 5 (21%) of all childbirths. In five countries (Dominican Republic, Brazil, Cyprus, Egypt and Turkey), caesarean sections now outnumber vaginal deliveries.

This number is set to continue increasing over the coming decade, with nearly a third (29%) of all births likely to take place by caesarean section by 2030, the research finds.

While a caesarean section can be an essential and lifesaving surgery, it can put women and babies at unnecessary risk of short and long-term health problems if performed when there is not medical need.

“Caesarean sections are absolutely critical to save lives in situations where vaginal deliveries would pose risks, so all health systems must ensure timely access for all women when needed,” said Dr Ian Askew, Director of WHO’s Department of Sexual and Reproductive Health and Research and the UN joint programme, HRP[2]. “But not all the caesarean sections carried out at the moment are needed for medical reasons. Unnecessary surgical procedures can be harmful, both for a woman and her baby.”

Caesarean sections can be essential in situations such as prolonged or obstructed
labour, foetal distress, or because the baby is presenting in an abnormal position.
However, as with all surgeries, they can have risks. These include the potential for heavy bleeding or infection, slower recovery times after childbirth, delays in establishing breastfeeding and skin-to-skin contact, and increased likelihood of
complications in future pregnancies.

There are significant discrepancies in a woman’s access to caesarean sections,
depending on where in the world she lives. In the least developed countries, about 8% of women gave birth by caesarean section with only 5% in sub-Saharan Africa,
indicating a concerning lack of access to this lifesaving surgery.

Conversely, in Latin America and the Caribbean, rates are as high as 4 in 10 (43%) of all births.

Worldwide caesarean section rates have risen from around 7% in 1990 to 21% today, and are projected to continue increasing over this current decade. If this trend continues, by 2030 the highest rates are likely to be in Eastern Asia (63%), Latin America and the Caribbean (54%), Western Asia (50%), Northern Africa (48%) Southern Europe (47%) and Australia and New Zealand (45%), the research suggests.

Causes of high caesarean section usage vary widely between and within countries. Drivers include health sector policies and financing, cultural norms, perceptions and practices, rates of preterm births, and quality of healthcare.

Rather than recommending specific target rates, WHO underscores the importance of focusing on each woman’s unique needs in pregnancy and childbirth.

“It’s important for all women to be able to talk to healthcare providers and be part of the decision making on their birth, receiving adequate information including the risks and benefits. Emotional support is a critical aspect of quality care throughout pregnancy and childbirth,” said Dr Ana Pilar Betran, Medical Officer at WHO and HRP.

WHO recommends some non-clinical actions that can reduce medically unnecessary use of caesarean sections, within the overall context of high quality
and respectful care:

  • Educational interventions that engage women actively in planning for their birth such as childbirth preparation workshops, relaxation programmes and psychosocial support where desired, for those with fear of pain or anxiety. Implementation of such initiatives should include ongoing monitoring and evaluation.
  • Use of evidence-based clinical guidelines, performing regular audits of caesarean section practices in health facilities, and providing timely feedback to health professionals about the findings.
  • Requirement for a second medical opinion for a caesarean section decision in settings where this is possible.
  • For the sole purpose of reducing caesarean sections, some interventions have been piloted by some countries but require more rigorous research:

– A collaborative midwifery-obstetrician model of care, for which care is provided primarily by midwives, with 24-hour back-up from a dedicated obstetrician
– Financial strategies that equalize the fees charged for vaginal births and caesarean sections.

References
[1] Trends and projections of caesarean section rates: global and regional estimates.
BMJ Global Health https://gh.bmj.com/content/6/6/e005671.full
[2] UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP)


Researchers assemble comprehensive RNA-atlas

Together with Baylor College of Medicine and the world’s leading sequencing company, Illumina, researchers at Ghent University have built one of the most comprehensive catalogues of the human transcriptome ever. By cleverly combining complementary sequencing techniques they have deepened our understanding of the function of known RNA molecules and discovered thousands of new RNAs. A better understanding of our transcriptome is essential to better understand disease processes and uncover novel genes that may serve as therapeutic targets or biomarkers.

The article ‘The RNA Atlas expands the catalog of human non-coding RNAs’, published in Nature Biotechnology, is the result of more than five years of work to further unravel the complexity of the human transcriptome. Never before has such a comprehensive effort been undertaken to characterize all RNA- molecules in human cells and tissues.

Our transcriptome is – analogous to our genome – the sum of all RNA molecules that are transcribed from the DNA strands that make up our genome. However, there’s no 1-on-1 relationship with the latter. Firstly, each cell and tissue has a unique transcriptome, with varying RNA production and compositions, including tissue-specific RNAs. Secondly, not all RNAs are transcribed from typical – protein coding – genes that eventually produce proteins. Many of our RNA molecules are not used as a template to build proteins, but originate from what once was called junk DNA: long sequences of DNA with unknown functions.

These non-coding RNAs (ncRNAs) come in all kinds of shapes and sizes: short, long, and even circular RNAs. Many of them even lack the tail of adenine-molecules that is typical for protein-coding RNAs.

“There have been other projects to catalogue our transcriptome but the RNA-Atlas project is unique because of the applied sequencing methods,” commented Prof. Pieter Mestdagh from the Center for Medical Genetics at Ghent University. “Not only did we look at the transcriptome of as many as 300 human cell and tissue types, but most importantly, we did so with three complementary sequencing technologies, one aimed at small RNAs, one aimed at polyadenylated (polyA) RNAs and a technique called total RNA sequencing.”

All data, analyses and results (equivalent to a few libraries of information) are available for download and interrogation in the R2 web portal, enabling the
community to implement this resource as a tool for exploration of non-coding RNA
biology and function.

Prof. Pavel Sumazin of the Baylor College of Medicine, said: “By combining all data in one comprehensive catalogue, we have created a new valuable resource for biomedical scientists around the world studying disease processes. A better understanding of the complexity of the transcriptome is indeed essential to better
understand disease processes and uncover novel genes that may serve as therapeutic
targets or biomarkers. The age of RNA therapeutics is swiftly rising – we’ve all witnessed the impressive creation of RNA vaccines, and already the first medicines that target RNA are used in the clinic. I’m sure we’ll see lots more of these therapies in the next years and decades.”

Reference
Lucia Lorenzi, Hua-Sheng Chiu et al. The RNA Atlas expands the catalog of human non-coding RNAs. Nature Biotechnology. 2021.
https://doi.org/10.1038/s41587-021-00936-1


Federation of Royal Colleges of Physicians approves UpToDate clinical decision support for CPD

UpToDate, the clinical decision support tool from Wolters Kluwer, Health has been approved by the Federation of the Royal Colleges of Physicians of the United Kingdom as a continuing professional development (CPD) activity. The organization is a collaboration between the Royal College of Physicians of London, Royal College of Physicians of Edinburgh, and Royal College of Physicians and Surgeons of Glasgow. The colleges have more than 50,000 members among them worldwide. The approval of UpToDate comes following new guidelines introduced by the Federation that recognize the use of online resources with current medical content (e-libraries) as CPD.

Members will now be able to earn and track credits eligible for continuing professional development while using UpToDate to research clinical questions at the point of care. CPD credits are earned from UpToDate by consulting information relevant to a specific clinical question, thus broadening clinical knowledge.

UpToDate will provide physicians and surgeons with quick and easy access to evidence-based clinical topics and recommendations. CPD credits can be earned through UpToDate anytime, anywhere, on desktop or mobile devices. According to research of UpToDate use in 2020, 1 in 4 clinicians (26%) in the UK and Ireland changed their course of action to a more appropriate treatment or diagnosis after consulting UpToDate.

Alaa Darwish, country manager – Middle East, Turkey and Africa, Clinical Effectiveness, Wolters Kluwer, Health, said: “With many UK-trained clinicians delivering healthcare services in the Middle East, UpToDate provides an invaluable resource for supporting evidence-based learning and meeting CPD requirements of the Federation of the Royal Colleges of Physicians of the United Kingdom as they care for patients.”

UpToDate from Wolters Kluwer contains over 12,000 clinical topics and more than 9,500 graded recommendations to support better clinical decisions at the point of care. A rigorous editorial process is implemented by 50 physician editors on staff who work with over 7,300 expert authors, editors, and peer-reviewers from 50 countries around the world to continuously publish evidence-based clinical information and recommendations.


WHO issues new recommendations on human genome editing

Two new companion reports[1] released July 12 by the World Health Organization (WHO) provide the first global recommendations to help establish human genome editing as a tool for public health, with an emphasis on safety, effectiveness and ethics.

The forward-looking new reports result from the first broad, global consultation looking at somatic, germline and heritable human genome editing. The consultation, which spanned over two years, involved hundreds of participants representing diverse perspectives from around the world, including scientists and researchers, patient groups, faith leaders and indigenous peoples.

“Human genome editing has the potential to advance our ability to treat and cure disease, but the full impact will only be realized if we deploy it for the benefit of all people, instead of fueling more health inequity between and within countries,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General.

Potential benefits of human genome editing include faster and more accurate diagnosis, more targeted treatments and prevention of genetic disorders. Somatic gene therapies, which involve modifying a patient’s DNA to treat or cure a disease, have been successfully used to address HIV, sickle-cell disease and transthyretin amyloidosis. The technique could also vastly improve treatment for a variety of cancers.

However, some risks exist, for example, with germline and heritable human genome editing, which alter the genome of human embryos and could be passed on to subsequent generations, modifying descendants’ traits.

The reports deliver recommendations on the governance and oversight of human genome editing in nine discrete areas, including human genome editing registries; international research and medical travel; illegal, unregistered, unethical or unsafe research; intellectual property; and education, engagement and empowerment. The recommendations focus on systems-level improvements needed to build capacity in all countries to ensure that human genome editing is used safely, effectively, and ethically.

The reports also provide a new governance framework that identifies specific tools, institutions and scenarios to illustrate practical challenges in implementing, regulating and overseeing research into the human genome. The governance framework offers concrete recommendations for dealing with specific scenarios such as:

  • A hypothetical clinical trial of somatic human genome editing for sickle cell disease proposed to take place in West Africa
  • Proposed use of somatic or epigenetic genome editing to enhance athletic performance
  • An imaginary clinic based in a country with minimal oversight of heritable human genome editing that offers these services to international clients following in vitro fertilization and preimplantation genetic diagnosis

“These new reports from WHO’s Expert Advisory Committee represent a leap forward for this area of rapidly emerging science,” said Dr Soumya Swaminathan, WHO’s Chief Scientist. “As global research delves deeper into the human genome, we must minimize risks and leverage ways that science can drive better health for everyone, everywhere.”

Going forward, WHO will:

  • Convene a small expert committee to consider next steps for the Registry, including how to better monitor clinical trials using human genome editing technologies of concern
  • Convene multisector stakeholders to develop an accessible mechanism for
    confidential reporting of concerns about possibly illegal, unregistered, unethical
    and unsafe human genome editing research and other activities
  • As part of a commitment to increase ‘education, engagement and empowerment’,
    lead regional webinars focusing on regional/local needs. Work within the Science Division to consider how to build an inclusive global dialogue on frontier technologies, including cross-UN working and the creation of web-based resources for reliable information on frontier technologies, including human genome editing.

Reference
[1] https://www.who.int/publications/i/item/9789240030381

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