Science – Policy Forum: Regulation of predictive analytics in medicine

Featured Journal Content

22 February 2019 Vol 363, Issue 6429
Policy Forum
Regulation of predictive analytics in medicine
By Ravi B. Parikh, Ziad Obermeyer, Amol S. Navathe
Science22 Feb 2019 : 810-812 Restricted Access
Algorithms must meet regulatory standards of clinical benefit
Artificial intelligence (AI) and increased computing power have long held the promise of improving prediction and prognostication in health care (1). Now, use of predictive analytics and AI in medicine, though with fits and starts, is transitioning from hype to reality: Several commercial algorithms have received regulatory approval for broad clinical use. But the barrier for entry of new advanced algorithms has been low. To unlock the potential of advanced analytics while protecting patient safety, regulatory and professional bodies should ensure that advanced algorithms meet accepted standards of clinical benefit, just as they do for clinical therapeutics and predictive biomarkers. External validation and prospective testing of advanced algorithms are clearly needed (2), but recent regulatory clearances raise concerns over the rigor of this process. Given these concerns, we propose five standards to guide regulation of devices based on predictive analytics and AI. Although well-established research standards, such as the TRIPOD Checklist, exist for developing and validating multivariable prediction models in medicine (3), our standards provide regulatory guidance for such algorithms prior to implementation in clinical settings.


Public Health Emergency of International Concern (PHEIC)
Polio this week as of 20 February 2019
:: On 19 February, the 20th IHR Emergency Committee including members, advisers, and invited Member States convened to discuss the status of international spread of poliovirus. The Committee unanimously agreed that the risk of polio spread continues to be a Public Health Emergency of International Concern (PHEIC) and proposed an extension of Temporary Recommendations for an additional three months. The recommendations come amid outbreak notification of cVDPV1 and cVDPV2 in Indonesia and Mozambique respectively. The official WHO Statement and the Temporary Recommendations will be issued shortly. [Full statement not yet posted]

:: The GPEI has developed the Global Polio Surveillance Action Plan 2018-2020, incorporating newer strategies and innovations to help endemic, outbreak and high-risk countries measure and enhance sensitivity of their surveillance systems. Read more here.

:: WHO is seeking input on draft guidance for managing human exposure to live polioviruses in facilities such as labs and vaccine plants. The document is open for public comment and WHO is particularly seeking feedback from national authorities for containment and others working in public health.
Summary of new viruses this week:
:: Afghanistan — one case of wild poliovirus type 1 (WPV1) and four WPV1-positive environmental samples;
:: Pakistan – two cases of WPV1 and four WPV1-positive environmental samples.

Editor’s Note:
WHO has posted a refreshed emergencies page which presents an updated listing of Grade 3,2,1 emergencies as below.

WHO Grade 3 Emergencies  [to 23 Feb 2019]
Democratic Republic of the Congo
:: :: 29: Situation report on the Ebola outbreak in North Kivu  19 February 2019
:: DONSEbola virus disease – Democratic Republic of the Congo   21 February 2019

Bangladesh – Rohingya crisis
:: Bi‐weekly Situation Report 3 – 14 February 2019
Vaccination at Registration Post: Three vaccination posts have been established in camp 7, camp 17 and 26 with the support of UNHCR to provide immunization service to newborn eligible for birth registration under family head count. The activity started in Teknaf in Sep 2018 and in Ukhia (camp 7 and 17) in Feb 2019. Immunization activities are offered for 5 days a week.
Health worker immunization: Two vaccinations post are providing immunization to health care workers on weekly basis to humanitarian workers in camps. To-date 1,753 Td doses have been administered to health workers.
VPD Surveillance: 3 AFP cases have been investigated in 2019 with result still pending. Out of 88 suspected measles cases in 2019, 53 patients (42%) have been investigated through Case Report Form.

South Sudan
::  WHO provides lifesaving health care services to displaced populations and host communities in 22 locations in South Sudan  18 February 2019

Myanmar – No new digest announcements identified  
Nigeria – No new digest announcements identified  
Somalia – No new digest announcements identified
Syrian Arab Republic – No new digest announcements identified  
Yemen – No new digest announcements identified


WHO Grade 2 Emergencies  [to 23 Feb 2019]
Brazil (in Portugese) – No new digest announcements identified
Cameroon  – No new digest announcements identified
Central African Republic  – No new digest announcements identified
Ethiopia – No new digest announcements identified
Hurricane Irma and Maria in the Caribbean – No new digest announcements identified
Iraq – No new digest announcements identified
Libya – No new digest announcements identified
MERS-CoV – No new digest announcements identified
Niger – No new digest announcements identified
occupied Palestinian territory  – No new digest announcements identified
Sao Tome and Principe Necrotizing Cellulitis (2017) – No new digest announcements identified
Sudan – No new digest announcements identified
Ukraine – No new digest announcements identified
Zimbabwe – No new digest announcements identified


WHO Grade 1 Emergencies  [to 23 Feb 2019]
Indonesia – Sulawesi earthquake 2018
Lao People’s Democratic Republic
Namibia – viral hepatitis
Philippines – Tyhpoon Mangkhut


UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises. 
Syrian Arab Republic   
:: Humanitarian Update Syrian Arab Republic – Issue 01 | 19 February 2019

. People in need of humanitarian assistance 13M
. People in acute need of humanitarian assistance 5.2M
. Internally displaced people (as of August) 6.2M
. Returnees (January – December 2018) 1.4 M
. People in need in UN-declared hardto-reach areas 1.1M
. 3.36 billion requested (US$)
. 64.9% funded

Yemen – No new digest announcements identified


UN OCHA – Corporate Emergencies
When the USG/ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field.
:: Ethiopia Humanitarian Bulletin Issue #3 | 04-17 February 2019
. Over 45,000 IDPs in need of urgent humanitarian assistance in Central Gondar.
. The level of humanitarian needs in 2019 expected to remain similar to 2018.
. UNHCR notes spontaneous movement of South Sudanese refugees in Ethiopia.

Somalia  – No new digest announcements identified

The Sentinel

Human Rights Action :: Humanitarian Response :: Health :: Education :: Heritage Stewardship ::
Sustainable Development
Week ending 16 February 2019

This weekly digest is intended to aggregate and distill key content from a broad spectrum of practice domains and organization types including key agencies/IGOs, NGOs, governments, academic and research institutions, consortia and collaborations, foundations, and commercial organizations. We also monitor a spectrum of peer-reviewed journals and general media channels. The Sentinel’s geographic scope is global/regional but selected country-level content is included. We recognize that this spectrum/scope yields an indicative and not an exhaustive product. Comments and suggestions should be directed to:

David R. Curry
GE2P2 Global Foundation – Governance, Evidence, Ethics, Policy, Practice

PDF: The Sentinel_ period ending 16 Feb 2019

:: Week in Review  [See selected posts just below]
:: Key Agency/IGO/Governments Watch – Selected Updates from 30+ entities   [see PDF]
:: INGO/Consortia/Joint Initiatives Watch – Media Releases, Major Initiatives, Research:: Foundation/Major Donor Watch -Selected Updates
:: Journal Watch – Key articles and abstracts from 100+ peer-reviewed journals  [see PDF]

ISIL/Da’esh Continues Evolution into Covert Global Network Enjoying Access to Millions of Dollars, Top Anti-Terrorism Official Tells Security Council

Governance: Non-state Actors – ISIL/Da’esh

ISIL/Da’esh Continues Evolution into Covert Global Network Enjoying Access to Millions of Dollars, Top Anti-Terrorism Official Tells Security Council
Counter-Terrorism Directorate Chief Concerned That Group Exploits Mobile Money Payments, Anonymity of Blockchain Technology
11 February 2019
Despite the decline in the number of international terrorist attacks in 2018, Islamic State in Iraq and the Levant () continues to evolve into a global covert network, with access to hundreds of millions of dollars and the demonstrated ability to exploit new technologies, the top-ranking United Nations counter-terrorism officials told the Security Council today.

Vladimir Voronkov, Under-Secretary-General in the United Nations Office of Counter-Terrorism, briefed the 15-member Council on the eighth “Report of the Secretary-General on the threat posed by ISIL to international peace and security and on the range of the United Nations’ efforts in support of Member States in countering the threat”. He said the threat has been increased by the presence of returning, relocating or released foreign terrorist fighters.

With ISIL’s centre of gravity in Iraq and Syria, where it is reported to control between 14,000 and 18,000 militants, the group remains intent on undermining any form of stabilization, he emphasized. Despite its loss of revenues, ISIL sustains its operations through accessible reserves or investment in businesses ranging from $50 million to $300 million. “Recent ISIL losses should not lead to complacency at any level,” he stressed.

He went on to outline efforts undertaken by the United Nations in countering the financing of terrorism, border control enforcement and countering terrorist narratives. Noting that ISIL continues to target Libya’s police stations and oil facilities, he said approximately 1,000 foreign terrorist fighters are also reported to have travelled from the western Balkans to conflict zones in Iraq and Syria. ISIL is also reported to control training camps in Afghanistan and is increasingly recruiting women and youngsters in its South-East Asia terrorist operations.

In a second briefing, Michèle Coninsx, Executive Director of the Counter Terrorism Committee Executive Directorate, cited with concern ISIL’s use of mobile payment services in West Africa and its possible exploitation of the anonymity afforded by blockchain technology. On advancing justice and accountability, she emphasized the fundamental need to collect and preserve evidence, pointing out that Governments can also establish special investigative and prosecutorial entities to support criminal justice efforts, welcoming the establishment of the United Nations Investigative Team to Promote Accountability for Crimes Committed by Da‘esh/Islamic State in Iraq and the Levant (UNITAD) in that context…

United Nations seeks US$920 million for Rohingya humanitarian crisis in 2019

Humanitarian Response – Scale: Rohingya in Bangladesh

United Nations seeks US$920 million for Rohingya humanitarian crisis in 2019
15 Feb 2019
United Nations aid agencies and NGO partners launched today the 2019 Joint Response Plan (JRP) for the Rohingya humanitarian crisis. The appeal seeks to raise US$920 million to meet the massive needs of more than 900,000 refugees from Myanmar and over 330,000 vulnerable Bangladeshis in host communities.

Critical aid and services such as food, water, sanitation and shelter represent more than half of the funding needs this year. Other key sectors of the appeal include health, site management, protection activities including child protection and addressing sexual and gender-based violence, education and nutrition.

More than 745,000 Rohingya refugees have fled from Myanmar’s Rakhine State to Bangladesh since August 2017, escaping violence in Myanmar and joining roughly 200,000 others already displaced in the Cox’s Bazar area by previous cycles of violence.

With the generosity and support of the Bangladeshi authorities and local communities, who were the first to respond to the emergency, critical needs were met and many lives were saved.

“The solidarity shown by the Government of Bangladesh and the commitment of humanitarian partners ensured the successful implementation of the first Joint Response Plan in 2018. Moving forward, we reiterate our commitment to meeting the dire needs of this population and urge the international community to support these efforts,” said International Organization for Migration Director General António Vitorino.

“Our humanitarian imperative today is to stabilise the situation of stateless Rohingya refugees and their Bangladesh hosts. We are hoping for timely, predictable and flexible contributions in order to meet the goals of this year’s appeal,” said the UN High Commissioner for Refugees Filippo Grandi.

“But while we tackle these immediate humanitarian needs we must not lose sight of solutions. I repeat my call to Myanmar to take urgent action to address the root causes of this crisis which have persisted for decades, so that people are no longer forced to flee and can eventually return home in safety and dignity. We encourage countries in this region and beyond to show solidarity with Bangladesh and to support Myanmar to start creating conditions for voluntary, safe and dignified return of Rohingya refugees,” Grandi continued.

The new JRP sets out a comprehensive humanitarian effort shaped around three strategic objectives. By bringing together 132 partners – UN agencies, international and national NGOs and government bodies in a collective effort – the Plan aims to deliver protection to refugee women, men, girls and boys, provide life-saving assistance and foster social cohesion.

The 2019 JRP is the third joint humanitarian appeal and builds on achievements made thus far in order to further stabilize the situation of Rohingya refugees…

UNHCR and UNICEF urge action in Europe to end childhood statelessness

Human Rights – Statelessness

UNHCR and UNICEF urge action in Europe to end childhood statelessness
GENEVA, 14 February 2019 – UNHCR, the UN Refugee Agency, and UNICEF, the UN Children’s Agency, are calling on States and regional organisations to take urgent action to ensure no child is born, or remains, stateless in Europe.

While there are no precise figures on the total numbers of stateless children, more than half a million people in Europe are estimated to be stateless.

As the overall number of asylum-seeking children in Europe has grown since 2010, with peaks in 2015 and 2016, so has the number of children identified as ‘stateless’. In 2017 some 2,100 children were registered as ‘stateless’, which represented a four-fold increase compared to 2010.

Children without a nationality have limited access to basic rights and services such as education and healthcare and can face life-long discrimination. Lack of official documents can put children at greater risk of experiencing violence, abuse and trafficking, and place them and their families at risk of arrest and detention.

“Life is stacked against a stateless child right from the start. Like all of us, they can dream, and they can hope, but the legal obstacles they face often mean their dreams are dashed before they are adults, and their potential squandered,” said Pascale Moreau, UNHCR’s Director of the Bureau for Europe.

Three groups of children are particularly affected:
:: Children who are born stateless in Europe. These include children who cannot inherit their parents’ nationality due to gender discrimination and gaps in nationality laws, and those who are stateless because their parents are.
:: Children born in Europe whose births are not registered, including children in vulnerable minority populations like the Roma.
:: Children from countries with known stateless populations who come to Europe as refugees and asylum-seekers.

“Every child has the right to a name and a nationality,” said Afshan Khan, UNICEF Regional Director for Europe and Central Asia, and Special Coordinator for the Refugee and Migrant Response in Europe.

“Governments not only have a responsibility to adopt safeguards that prevent a child from being born stateless, but to provide legal aid and support to ensure every stateless child realizes their right to citizenship.”

To better address child statelessness in Europe, UNICEF and UNHCR are proposing a series of low-cost, effective and sustainable solutions, including:
:: Ensuring that every stateless refugee or migrant child is properly identified and protected upon arrival in Europe.
:: Simplifying procedures to enable stateless children to acquire a nationality as soon as possible.
:: Adopting or amending legislation to include safeguards granting nationality to all children born in a country who would otherwise be stateless.

While birth registration rates are high in Europe, information campaigns targeting families most at risk of statelessness would help identify unregistered children and support families through registration procedures.

Achieving legal identity for all through birth registration is one of the goals of the 2030 Sustainable Development Agenda. UNICEF works to ensure all children are registered at birth, while UNHCR’s #IBelong Campaign aims to end statelessness, which affects millions of people worldwide, by 2024.


Global Governance – World Religions

(3-5 FEBRUARY 2019)
[Introduction Excerpts]
…From our fraternal and open discussions, and from the meeting that expressed profound hope in a bright future for all human beings, the idea of this Document on Human Fraternity was conceived. It is a text that has been given honest and serious thought so as to be a joint declaration of good and heartfelt aspirations. It is a document that invites all persons who have faith in God and faith in human fraternity to unite and work together so that it may serve as a guide for future generations to advance a culture of mutual respect in the awareness of the great divine grace that makes all human beings brothers and sisters.

[Document Excerpts]
…In the name of God and of everything stated thus far; Al-Azhar al-Sharif and the Muslims of the East and West, together with the Catholic Church and the Catholics of the East and West, declare the adoption of a culture of dialogue as the path; mutual cooperation as the code of conduct; reciprocal understanding as the method and standard.

We, who believe in God and in the final meeting with Him and His judgment, on the basis of our religious and moral responsibility, and through this Document, call upon ourselves, upon the leaders of the world as well as the architects of international policy and world economy, to work strenuously to spread the culture of tolerance and of living together in peace; to intervene at the earliest opportunity to stop the shedding of innocent blood and bring an end to wars, conflicts, environmental decay and the moral and cultural decline that the world is presently experiencing.

We call upon intellectuals, philosophers, religious figures, artists, media professionals and men and women of culture in every part of the world, to rediscover the values of peace, justice, goodness, beauty, human fraternity and coexistence in order to confirm the importance of these values as anchors of salvation for all, and to promote them everywhere.

This Declaration, setting out from a profound consideration of our contemporary reality, valuing its successes and in solidarity with its suffering, disasters and calamities, believes firmly that among the most important causes of the crises of the modern world are a desensitized human conscience, a distancing from religious values and a prevailing individualism accompanied by materialistic philosophies that deify the human person and introduce worldly and material values in place of supreme and transcendental principles.

While recognizing the positive steps taken by our modern civilization in the fields of science, technology, medicine, industry and welfare, especially in developed countries, we wish to emphasize that, associated with such historic advancements, great and valued as they are, there exists both a moral deterioration that influences international action and a weakening of spiritual values and responsibility. All this contributes to a general feeling of frustration, isolation and desperation leading many to fall either into a vortex of atheistic, agnostic or religious extremism, or into blind and fanatic extremism, which ultimately encourage forms of dependency and individual or collective self-destruction.

History shows that religious extremism, national extremism and also intolerance have produced in the world, be it in the East or West, what might be referred to as signs of a “third world war being fought piecemeal”. In several parts of the world and in many tragic circumstances these signs have begun to be painfully apparent, as in those situations where the precise number of victims, widows and orphans is unknown. We see, in addition, other regions preparing to become theatres of new conflicts, with outbreaks of tension and a build-up of arms and ammunition, and all this in a global context overshadowed by uncertainty, disillusionment, fear of the future, and controlled by narrow-minded economic interests.

We likewise affirm that major political crises, situations of injustice and lack of equitable distribution of natural resources – which only a rich minority benefit from, to the detriment of the majority of the peoples of the earth – have generated and continue to generate, vast numbers of poor, infirm and deceased persons. This leads to catastrophic crises that various countries have fallen victim to despite their natural resources and the resourcefulness of young people which characterize these nations. In the face of such crises that result in the deaths of millions of children – wasted away from poverty and hunger – there is an unacceptable silence on the international level.

It is clear in this context how the family as the fundamental nucleus of society and humanity is essential in bringing children into the world, raising them, educating them, and providing them with solid moral formation and domestic security. To attack the institution of the family, to regard it with contempt or to doubt its important role, is one of the most threatening evils of our era…

…The first and most important aim of religions is to believe in God, to honour Him and to invite all men and women to believe that this universe depends on a God who governs it. He is the Creator who has formed us with His divine wisdom and has granted us the gift of life to protect it. It is a gift that no one has the right to take away, threaten or manipulate to suit oneself. Indeed, everyone must safeguard this gift of life from its beginning up to its natural end. We therefore condemn all those practices that are a threat to life such as genocide, acts of terrorism, forced displacement, human trafficking, abortion and euthanasia. We likewise condemn the policies that promote these practices.

Moreover, we resolutely declare that religions must never incite war, hateful attitudes, hostility and extremism, nor must they incite violence or the shedding of blood. These tragic realities are the consequence of a deviation from religious teachings. They result from a political manipulation of religions and from interpretations made by religious groups who, in the course of history, have taken advantage of the power of religious sentiment in the hearts of men and women in order to make them act in a way that has nothing to do with the truth of religion. This is done for the purpose of achieving objectives that are political, economic, worldly and short-sighted. We thus call upon all concerned to stop using religions to incite hatred, violence, extremism and blind fanaticism, and to refrain from using the name of God to justify acts of murder, exile, terrorism and oppression…

– Freedom is a right of every person: each individual enjoys the freedom of belief, thought, expression and action. The pluralism and the diversity of religions, colour, sex, race and language are willed by God in His wisdom, through which He created human beings. This divine wisdom is the source from which the right to freedom of belief and the freedom to be different derives. Therefore, the fact that people are forced to adhere to a certain religion or culture must be rejected, as too the imposition of a cultural way of life that others do not accept;

– Justice based on mercy is the path to follow in order to achieve a dignified life to which every human being has a right;…

– Terrorism is deplorable and threatens the security of people, be they in the East or the West, the North or the South, and disseminates panic, terror and pessimism, but this is not due to religion, even when terrorists instrumentalize it. It is due, rather, to an accumulation of incorrect interpretations of religious texts and to policies linked to hunger, poverty, injustice, oppression and pride. This is why it is so necessary to stop supporting terrorist movements fuelled by financing, the provision of weapons and strategy, and by attempts to justify these movements even using the media. All these must be regarded as international crimes that threaten security and world peace. Such terrorism must be condemned in all its forms and expressions;

The concept of citizenship is based on the equality of rights and duties, under which all enjoy justice. It is therefore crucial to establish in our societies the concept of full citizenship and reject the discriminatory use of the term minorities which engenders feelings of isolation and inferiority. Its misuse paves the way for hostility and discord; it undoes any successes and takes away the religious and civil rights of some citizens who are thus discriminated against;…

– It is an essential requirement to recognize the right of women to education and employment, and to recognize their freedom to exercise their own political rights. Moreover, efforts must be made to free women from historical and social conditioning that runs contrary to the principles of their faith and dignity. It is also necessary to protect women from sexual exploitation and from being treated as merchandise or objects of pleasure or financial gain. Accordingly, an end must be brought to all those inhuman and vulgar practices that denigrate the dignity of women. Efforts must be made to modify those laws that prevent women from fully enjoying their rights;

– The protection of the fundamental rights of children to grow up in a family environment, to receive nutrition, education and support, are duties of the family and society. Such duties must be guaranteed and protected so that they are not overlooked or denied to any child in any part of the world. All those practices that violate the dignity and rights of children must be denounced. It is equally important to be vigilant against the dangers that they are exposed to, particularly in the digital world, and to consider as a crime the trafficking of their innocence and all violations of their youth;

– The protection of the rights of the elderly, the weak, the disabled, and the oppressed is a religious and social obligation that must be guaranteed and defended through strict legislation and the implementation of the relevant international agreements…

Abu Dhabi, 4 february 2019
His Holiness Pope Francis
The Grand Imam of Al-Azhar Ahmad Al-Tayyeb