Getting more vaccines in arms: Trust and efficiencies

Guest blog by Farah Towfic, PharmD, MBA, director of the U.S. Pharmacopeia COVID-19 Vaccine Handling Toolkit

In the United States, nearly 200 million doses of influenza vaccines are administered annually. Clearly, pharmacists, nurses, physicians, and other healthcare practitioners have demonstrated a successful track record of delivering robust immunization programs for many years. However, the unprecedented scale and speed at which the COVID-19 vaccinations must be delivered to curb the devastating impact of this pandemic has surfaced enormous challenges—which have been further compounded by significant vaccine supply demand.​ Never before have we had to distribute multiple doses to more than 15 billion individuals around the world, with more than 300 million in the U.S. alone.

The pandemic has also recharged the focus on vaccine hesitancy, a challenging and complex issue which, at its core, is about trust based on a person’s experience and perspective. According to the KFF COVID-19 Vaccine Monitor, a growing share of the public is open to getting vaccinated, but many of the same groups that were hesitant in December 2020, when the first COVID-19 vaccines were released, remain hesitant now. When deciding whether to get vaccinated, most people say they will likely turn to pharmacists, doctors, nurses, and healthcare providers as the source for information. The KFF COVID-19 Vaccine Monitor also notes that 85 percent of people trust their own doctor or healthcare provider at least a fair amount for reliable vaccine information.

If we are going to mitigate the impact of this pandemic, we need to help build and maintain trust in COVID-19 vaccines. As an independent, nonprofit, scientific organization, U.S. Pharmacopeia (USP) has been dedicated—for more than 200 years—to improving global health and building trust in medicine through public standards and related programs that help ensure the quality, safety, and benefit of our drugs. With our shared goals to provide patient access to quality medicines, USP is proud to be a founding member of the National Consumers League (NCL) Health Advisory Council. The Council’s informative communication and opportunities for engagement provide critical perspectives that help shape and inform USP’s strategic focus and initiatives. The Health Advisory Council also demonstrates the power of collaboration—which is a cornerstone of USP’s work.

By working together with stakeholders, partners in industry and the U.S. government, we are able to identify the COVID-19 vaccine operational challenges and also provide solutions. One of these solutions is the recently released USP COVID-19 Vaccine Handling Toolkit, which addresses gaps that slow getting shots in arms and helps healthcare practitioners safely deliver vaccines in a variety of settings.

As millions of additional doses of COVID-19 vaccines are released, the USP COVID-19 Vaccine Handling Toolkit is helping doctors, nurses, pharmacists, and other healthcare practitioners create operational efficiencies to vaccinate more people in their communities quickly and safely, all the while maintaining quality. It includes strategies in three key areas:

  • Preparation and labeling to support different practitioners preparing and administering vaccines including how to maximize the number of doses per vial and enabling pre-drawing of vaccines in advance of large immunization events.
  • Storing, handling, and transporting the vaccine to mass vaccination clinics, nursing and long-term care facilities, and more.
  • Waste prevention and disposal to support settings in preventing vaccine waste and addressing gaps for vaccine administrators in proper disposal of ancillary supplies, such as syringes.

“Using the strategies from the USP Vaccine Handling Toolkit for pre-drawing syringes and streamlining our processes and workflow we increased shots in arms by 50% per day,” says Patricia W. Slattum, Pharm.D., Ph.D., BCGP, a vaccine administrator with the Virginia Medical Reserve Corp and Virginia Commonwealth University.

More than 40 independent expert volunteers along with U.S. government representatives developed this toolkit that enables healthcare practitioners to benefit from consistent, scientific-based strategies developed by independent experts that close efficiency gaps across states and territories.

The USP COVID-19 Vaccine Handling Toolkit is one of several initiatives USP is undertaking to support quality and build trust in COVID-19 vaccines, treatments, and preventatives. For example, our Hand Sanitizer Toolkit, launched in spring 2020, is being used by many around the world to ensure quality preparation of this essential COVID-19 preventative.

As the nation’s pioneer consumer organization, that leads the charge on the importance of adherence to live-savings medicines, NCL plays a pivotal role in helping to build trust in vaccines. USP values the opportunity to share the COVID-19 Vaccine Handling Toolkit with NCL and looks ahead to future opportunities to partner with NCL and other stakeholders in the patient advocacy community.

As more is learned about COVID-19 vaccines, additional information will be shared in the future. We encourage NCL’s readers to sign-up for updates at https://www.usp.org/covid-19/vaccine-handling-toolkit.

About USP
USP is an independent scientific organization that collaborates with the world’s top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. Through our standards, advocacy, and education, USP helps increase the availability of quality medicines, supplements, and food for billions of people worldwide.

Hispanic Heritage Month: Focus on the importance of participating in research through clinical trials

Hispanic Heritage Month: Focus on the importance of participating in research through clinical trials
by Elena Rios, MD, MSPH, FACP
President & CEO, National Hispanic Medical Association

The COVID-19 pandemic has impacted the world and the United States with a double threat: decreasing health and function of many, especially older patients with underlying diseases (obesity, asthma, diabetes, hypertension, etc.) that decrease the body’s immune response to fight off the virus; and millions left jobless as businesses downsize or close. In the healthcare arena, scientists and physicians are learning about the disease and how to treat it: We now know to limit ventilators to avoid high air pressures that can hurt damaged lungs; to place infected patients on their stomachs to allow lungs to expand; to use dexamethasone to decrease inflammation; and to use new antiviral therapies like Remdesivir and monoclonal antibodies. While there is no vaccine to prevent COVID-19, vaccine developers, researchers, and manufacturers are expediting the development of one.

The National Institutes of Health (NIH) and several pharmaceutical companies are conducting research through clinical trials that have found potential vaccines to be safe. This summer they started to enroll people and closely follow them for any adverse effects. Historically, Hispanics, Blacks, and Native Americans have been underrepresented in clinical trial research for a variety of factors, chief among them, a distrust of research and the concept of fatalism (leaving life’s challenges in God’s hands). But it is crucially important to have diversity in clinical trials to have information on the vaccine impact for Hispanics, for example. I encourage all persons over the age of 18 to enroll in the important COVID-19 clinical trials — and recommend websites for two ongoing clinical trials: the CoronaVirusPreventionNetwork.org from the NIH and Moderna, and the CovidVaccineStudy1.com

from Pfizer Inc. Each site provides consumers with information on the locations and how to enroll.

The National Hispanic Medical Association (NHMA) was established in 1994 to represent trusted Hispanic physicians and to improve the health of Hispanics and underserved populations. Given that, by 2042, one out of four people living in our nation will be Latino, NHMA has joined as a partner to encourage the Latino community to join the NIH All of Us Research Program. In May 2018, the NIH opened national enrollment for the All of Us Research Program—a momentous effort to advance individualized prevention, treatment, and care for people of all backgrounds—in collaboration with NHMA and other national partners. People ages 18 and older who reside in the United States, regardless of health status, are eligible to enroll. The overall aim is to enroll 1 million or more volunteers and to oversample communities that have historically been underrepresented in research to make the program the largest, most diverse resource of its kind. Our participation will provide information on how to better develop health care prevention and treatment programs for generations to come.

Precision medicine is an emerging approach to disease treatment and prevention that considers differences in people’s lifestyles, environments and biological makeup, including genes. By partnering with 1 million diverse people who share information about themselves over a 10-year period, the All of Us Research Program will enable research to more precisely prevent and treat a variety of health conditions.

Participants can access their own health information, including genetics information, summary data about the entire participant community, and information about studies and findings, that come from All of Us. Participants are asked to share different types of health and lifestyle information, through online surveys and electronic health records (EHRs), which will continue to be collected over the course of the program. At different times over the coming months and years, some participants will be asked to visit a local partner site to provide blood and urine samples and to have basic physical measurements taken, such as height and weight, to ensure that the program gathers information fromall types of people. This program is especially focused on those who have been underrepresented in research, but not everyone will be asked to give physical measures and samples. In the future, participants may be invited to share data through wearable devices and to join follow-up research studies, including clinical trials.

In addition, data from the program will be broadly accessible for research purposes. Ultimately, the All of Us Research program will be a rich and open data resource for traditional academic researchers as well as citizen scientists—and everyone in between. To learn more about the program and how to join, please visit https://www.JoinAllofUs.org.

About NHMA

NHMA is a nonprofit association representing the interests of 50,000 Hispanic physicians with the mission to improve the health of Hispanics in the U.S. For more information, please visit www.NHMAmd.org

The impact of COVID-19 on child labor

By Child Labor Coalition intern Ellie Murphy

Combatting child labor during a global pandemic is a staggering challenge. In countries like Ghana, the Ivory Coast, Bangladesh—and dozens more—school cancellations and lost family income may push children into the labor market. Once in, it may be hard for them to get out and return to school. In the face of this dire emergency, governments, the corporate world, and charitable institutions will need to support vulnerable families during this unprecedented time.

There is a strong correlation between access to education and preventing child labor. “Lack of access to education keeps the cycle of exploitation, illiteracy, and poverty going—limiting future options and forcing children to accept low-wage work as adults and to raise their own children in poverty,” noted the children’s advocacy group, Their World.

With nine in 10 children across the globe prevented from attending school in person, Human Rights Watch notes that interrupting formal education will have a huge impact on children and jeopardize their opportunity for better employment opportunities in the future: “For many children, the COVID-19 crisis will mean limited or no education, or falling further behind their peers.”

Poverty is the single greatest cause of child labor. Because many parents have lost or will lose their jobs, children are facing increased pressure to supplement family incomes. “Children work because their survival and that of their families depend on it, and in many cases because unscrupulous adults take advantage of their vulnerability,” notes the International Labour Organization.

Countries are being impacted by COVID-19 differently, but developing countries are expected to feel more negative consequences than developed countries, according to a report from WorldAtlas.com. Tourism and trade helps fuel many of these economies and the COVID pandemic has devastated both sectors.

Developing countries—primarily in Africa and Asia—already house 90 percent of working children, according to the International Journal of Health Sciences. Economic pressure from the pandemic will likely drive even more children into the workforce.

Before the pandemic, child labor in West Africa was widespread. 2.1 million child laborers were employed by cocoa farms in the Ivory Coast and 900,000 children on cocoa farms in Ghana, according to researchers from Tulane University. Ghana and the Ivory Coast produce about 60 percent of the world’s cocoa—a critical ingredient in chocolate. A recent Voice of America (VOA) article included predications that “there will be increased economic pressures on farming families, and ongoing school closures in Ghana [meaning] children are more likely to accompany their parents to their farms and be exposed to hazardous activities.”

The VOA cited research by the International Cocoa Initiative that analyzed the impacts of income loss on child labor rates in the Ivory Coast and found that a 10 percent drop in income for families in the cocoa industry is expected to produce a 5 percent increase in child labor.

Bangladesh, which had a reported 1.2 million children trapped in the worst forms of child labor in 2015, according to the ILO, is also at risk of seeing child labor increase. Most Bangladeshi workers—87 percent—earn money in the informal economy performing daily labor, unpaid work for their family, or piece-rate work. COVID-19 impacts have left families struggling with a severe drop in income of around 70 percent in many cases. Many adults and children who work making parts of products like garments have seen their income disappear entirely. “Those who depend on daily wages, for example, day labourers, rickshaw pullers, construction workers, street vendors, workers at small informal factories have lost their incomes with the hit of the pandemic,” noted researchers with the Institute for Development Studies. With this dramatic loss of income, it is expected that families will turn to their children to earn more money to buy basic necessities for survival.

In an effort to combat the potential increase in child labor, human rights organizations have urged governments to support families during this crisis—including the use of cash transfer programs. This entails direct cash payments to destitute families. Sometimes there are strings attached to the payments. Families that accept the money must promise to keep children in school and not allow them to enter the labor market. Cash transfers, often involving small amounts of money, have proven effective, in varying degrees, in reducing child labor in many countries.

In the COVID-19 pandemic, even small amounts of money might prevent starvation—or keep children out of the labor market. Save the Children argues that cash transfers help reduce the rate of child mortality, increase access to education, and reduce child abuse. Researchers Jacobus DeHoop and Eric Edmonds recently noted that 133 countries were working on social protection responses that provide financial support to vulnerable families in an effort to combat an increase in child labor during this time. Human Rights Watch has a series of recommendations for governments, including cash transfer payments.

Government efforts alone may not be enough. Companies that employ vulnerable demographics must also respond. Verité, an organization that works to eliminate abusive labor and empower workers, issued a series of recommendations to help companies address COVID impacts. Among the recommendations was a call for companies that work in areas with high rates of child labor to monitor “hot spots” for exploitation and intervene when necessary. Additionally, Verite urged companies to provide benefits for families who experience a loss of a parent due to the pandemic, make work remote when possible, and provide longer sick leaves for employees.

The COVID-19 crisis calls for innovative efforts to protect vulnerable families and children. As Jo Becker, the children’s rights advocacy director at Human Rights Watch, notes “the choices governments make now are crucial, not only to mitigate the worst harm of the pandemic, but also to benefit children over the long term.” By providing families with desperately needed resources during this unprecedented time, it may be possible to help curtail the increase of child labor worldwide.

In the last two decades, the world has seen the number of child laborers drop by nearly 100 million. “We do not want to see those hard-won gains reversed,” said Reid Maki, director of child labor advocacy for the National Consumers League and the coordinator of the Child Labor Coalition. “Concerted and robust action is required.” The actions that those in power take today will have long-lasting impacts that go far beyond COVID-19.

Ellie Murphy is a rising junior at Tufts University, majoring in International Relations and Sociology.

Lessons from pandemic life: we all need the option of paper notice

Jim Haigh leads education and development efforts at Keep Me Posted North America, an advocacy organization focused on the mission of consumer choice in essential communications.

It was only last year that a whopping 86 percent of U.S. consumers expressed the desire of having a choice for how they receive important information from the companies they do business with. For critical correspondence such as bills and statements, the overwhelming majority want the option of paper or electronic delivery, and the ability to control their preferences.

But as consumers trapped in the digital divide have pleaded for communications choices and relief from punishing paper fees, more and more companies have prioritized digital-first approaches to conducting business including how they send legal notice of account, tacking on new charges along the way. It might have been easy for some demographics and geographic regions to overlook this important issue, having taken for granted the luxury, convenience and complacency of a digital world where everything always just works amazing in a click. 

But the calamities we are all seeing and experiencing—as new realities unfold have changed all of that. With government and company websites crashing, servers overloading, networks slowing, transactions halted, records quarantined, Americans—and the world—are waking up daily to a new appreciation of the need to have paper options. Failsafe analog backups, like physical bank records or medical histories, become a necessity as untold millions try to apply for emergency aid and assistance, complete their tax filings or take care of their health. Or cast their vote and complete the Census.

The digital divide has always been here, but too often hiding in plain sight. As schools across the country attempted to roll out remote learning, the widespread lack of access to affordable connectivity spanned from rural to urban to everywhere in between. The same widespread gaps true of home computers, tablets, and devices able to run the latest applications or function across important websites. The nation watched as people stood unsafely in lines to get paper forms because digital options foreclosed. With stores closed or stay-at-home ordered to populations, suddenly even basic supplies overlooked like ink, toner, batteries for devices and broken devices waiting for repair, all combine to give everyone an unwelcome taste of the great digital divide we all share.

Now that so many of us are on the same page, it’s a perfect time to highlight the efforts of the Keep Me Posted North America campaign to restore and sustain consumers’ choice in how they receive important information—on paper or electronically—from their service providers. National Consumers League is an active member of the non-profit KMP coalition of consumer groups, charities and businesses, and champions their mission and efforts to ensure that every consumer in North America has the option of both paper and digital communications—free of charge—from the companies they routinely do business with.

KMP’s advocacy, resources, and tools are crucial for all consumers to have the facts and a strong, united voice. It is up to all of us to build grassroots support and influence service providers directly. Together, we are making a difference.

Please join with KMP in urging banks, utilities, telecommunications, and all recurring service providers to take action proactively to benefit customers now during the pandemic and beyond by adopting the Keep Me Posted Best Practices for communications choice in essential customer communications. Together we ask that they fully treat bills and statements as true notice of account. In so doing, they will transparently provide a range of paper and digital options, honor preferences, seek consent for changes, and pose no barriers for customers needing to switch back or forth from digital to paper notice—without any additional fees charged for either form of delivery. 

Let’s all help companies understand the bargain: for less than seventy cents per account per month, customers will have the unfettered access to all the account information they need, how they need it, in whatever form they need it at their moment in this crisis we all share in together. And furthermore, empowering consumers with that flexibility of seamless access and delivery of paper and electronic account information will probably pay dividends as a sound investment—in customer retention, and measurable savings in customer service down the road.

About Keep Me Posted North America

Keep Me Posted advocates for the right of every consumer in North America to choose, free of charge, how they receive important information—on paper or electronically—from their service providers. KMP is a coalition of consumer groups, charities, and businesses that are committed to protecting consumer access to paper-based communications at no extra charge. These consumers include older adults, the disabled, low-income households without computers, printers or broadband service, and people in rural areas where unreliable internet access is common.

For more information on how to support KMP or to become a member, visit our website at keepmepostedna.org, or follow us on Twitter, Facebook, or LinkedIn.

 

Protecting information privacy: challenges and opportunities in federal legislation

Polly Turner-Ward

By NCL Google Public Policy Fellow Pollyanna Turner-Ward

On September 11, 2019, policymakers, industry stakeholders, and consumer advocates gathered at The Brookings Institution to discuss the pressing question of how to protect information privacy through federal legislation. Representing the National Consumers League was Executive Director, Sally Greenberg.

How did we get here?

To set the scene, panelists first discussed why there is consensus on the need for federal legislation to address privacy and data security. The Snowden revelations showed consumers how much of their data is out there, and they began to question whether companies could be trusted to keep their data safe from the government. More recently, in light of the Cambridge Analytica scandal and increasing instances of identity theft and fraud resulting from data breaches, consumers have begun to question whether companies themselves can be trusted with their data.

Businesses are worried about lack of consumer trust interfering with their adoption of digital products and services. For instance, parental refusal to provide consent to the collection and use of data regarding their kid’s academic performance prevents the personalization of their children’s learning experience. By providing individuals with greater privacy protections, businesses hope that individual participation in the digital economy will increase.

In response to consumer privacy concerns, a patchwork of state bills on privacy and data security are also popping up. Business claims to be overwhelmed by the idea of complying with these differing regulatory schemes, especially in light of the EU’s General Data Protection Regulation (GDPR), which has already moved many organizations to comply with privacy and data security rules. To support businesses and to regain U.S. privacy leadership, greater international operability is necessary.

What should federal legislation look like?

Each panelist set forth their idea of what federal legislation should aim to achieve. Intel drafted a privacy bill which includes various protections but which lacks a private right of action – that is, the ability to take wrongdoers to court if they violate privacy laws. If companies promise not to use your information in certain ways and then do it anyway, in violation of law, you should have the right to take them to court. NCL’s Sally Greenberg directed audience members towards the Public Interest Privacy Principles signed by thirty-four consumer advocacy and civil rights organizations. Advocating in favor of strong protections, strong enforcement, and preemption, and highlighting the importance of “baking data privacy into products and services”, she offered NCL’s vision of a strong, agile and adaptive national standard.

Panelists drew comparisons between this approach and that of the EU’s GDPR, but criticized the time-consuming and resource intensive nature of that legislation. They agreed that U.S. legislation should avoid being too prescriptive in the details. Rather than requiring documentation of policies, practices, and data flow maps, legislation should focus on high-level issues.

Breaking down these issues according to consensus and complexity, Cameron F. Kelly listed covered information, de-identification, data security, state enforcement, accountability, and FTC authority as solvable issues. Implementation issues, he said, include notice and transparency and individual rights (access, portability, right to object to processing, deletion, nondiscrimination). However, Mr. Kelly noted that disagreement clouds a number of complex issues. These relate to algorithmic transparency, algorithmic fairness, and data processing limitations (use restrictions). Until consensus is reached in these areas, disagreements about preemption and private right of action are unlikely to be resolvable.

Notice and Transparency 

While notice and transparency are important aspects of a comprehensive approach towards privacy and data security, it is difficult for consumers to process the volume of information contained in privacy policies. Consumers also often have little choice but to “agree” to services that are essential to everyday life. As such, legislators may wish to explore the extent to which a company may force an individual to waive their privacy rights as a condition of service. Consent should only have a limited role in relation to sensitive data uses, and companies should focus on designing user interfaces to enable meaningful consumer consent. Panelists criticized the California Consumer Protection Act (CCPA) for its lack of detail and for putting the burden on individuals to protect themselves. It was agreed that federal standards should move beyond notice-and-consent and put the burden back on businesses.

De-identification 

One panelist called de-identification the “secret sauce” to privacy. Preserving the utility of data while removing identification puts the focus on data processing harms. It is important to get de-identification right for valuable research purposes. However, de-identification is often not done well and confusion lurks around pseudonymization. This technique involves replacing personally identifiable information fields within a data record with artificial identifiers. As data remains identifiable using that technique, data security and privacy risks remain. Companies must be incentivized to effectively de-identify data, to not re-identify, and to contractually restrict downstream users from doing the same. To avoid conflating data security levels with pseudonymization levels, a universal and adaptable de-identification standard must be developed.

Data security 

Because data security is critical to privacy, panelists agreed that it is the foundation upon which privacy legislation should be built. Panelists warned against an overly prescriptive approach towards data security but suggested that the Federal Trade Commission (FTC) should offer more guidance. “Reasonable” data security depends upon the nature and scope of data collection and use. This affords organizations flexibility when adopting measures that make sense in terms of information sensitivity, context, and risk of harm.

However, determining data security standards according to the risk of privacy harm is difficult because “risk of privacy harm” is an unsettled and controversial concept. It was also debated whether “information sensitivity” should be used to determine the reasonableness of data security standards. Public Knowledge argued that all data should be protected in the same way because the distinction between sensitive and non-sensitive data is increasingly questionable. When data is aggregated and sophisticated technologies such as machine learning are applied, each and every data point can lead back to an identifiable person.

While use of off-the-shelf software should generally be considered reasonable, higher standards should apply to companies that are more aggressive in their data collection and use. Extending to third party processors and service providers, organizations must continually develop physical, technical, and legal safeguards. To ensure robust infrastructure to secure their data, they should run tests, impact assessments, and put resources towards data mapping.

Data processing limitations

In sectors ranging from education to healthcare, the use of data undoubtedly has the potential to help us solve many societal problems. However, data use is pervasive, and new and unpredictably bad outcomes are also possible. Consumers want data to be used in ways that benefit them, for data not to be used in ways that harm them, and for their data to be protected. However, information collection and sharing is largely unbounded. If Congress wishes to move beyond a notice-and-consent model and put the burden back on organizations that handle data, then the boundaries of how data should be collected, retained, used, and shared must be confronted. Without limitations, the high value of data will continue to incentivize organizations to collect and retain data for the sake of it. These practices increase cybersecurity and privacy risks on unforeseen levels.

Calling out data brokers, Intel’s David Hoffman stated that databases containing lists of rape victims are simply “unacceptable.” However, transfer restrictions are likely to be one of the hardest areas to reach consensus on. Use restrictions, which relate to what organizations can and cannot do with data at a granular level, may be approached by creating presumptively allowed and presumptively prohibited lists. Use and sharing could be presumptively allowed for responsible advertising, legal process and compliance, data security and safety, authentication, product recalls, research purposes, and the fulfillment of product and service requests. Meanwhile, use of data for eligibility determinations, committing fraud or stalking, or for unreasonable practices could be presumptively prohibited.

However, it is difficult to determine the standards by which a particular data use should be “green-lighted” or “red-lighted.” To determine if a data use is for a purpose related to that which a user originally shared data, factors may be considered such as whether the use is primary or secondary, how far down the chain of vendors processing occurs, and whether the processor has a direct or indirect relationship with the data subject. The FTC has done work to articulate “unreasonable” data processing and sharing, and the Center for Democracy and Technology’s Consumer Bill of Rights emphasizes respect for context (user expectations) by laying out applicable factors such as consumer privacy risk and information sensitivity.

However, “context” is difficult to operationalize. One option may be to grant the FTC rulemaking authority to determine issues such as which data uses are per se unfair, or which information is sensitive. The deception and unfairness standard has guided the FTC for decades. However, panelists were concerned about giving the FTC a blank check to use the abusiveness standard to deal with data abuses. Instead, the FTC could be given a clear set of instructions in the form of FTC guidance, legislative preamble, or written in detail in the legislation. If this approach is taken, it would be necessary to confront the difficult question of what harm legislation should seek to address. Because privacy injury is not clear or quantifiable, it is difficult to agree on the appropriate harm standard. A specific list of the types of injury – not an exhaustive list – resulting from data processing would give the harm standard substance, and algorithmic data processing ought to be directly confronted.

Because the purpose of data analysis is to draw differences and to make distinctions, the privacy debate cannot be separated from the discrimination debate. Intent to engage in prohibited discrimination is difficult to prove, especially with use of proxies. For instance, rather than directly using a protected characteristic such as racial heritage as a proxy to offer payday loans, an algorithm could use zip code or music taste as a proxy for race in order to decide who to advertise payday loans to. To provide clarity and to promote algorithmic fairness, existing discrimination laws could be augmented with privacy legislation by defining unfair discrimination according to disparate impact on protected classes (disadvantaged groups). Privacy legislation should ensure that data use does not contribute to prohibited discrimination by requiring risk assessments and outcome monitoring.

To increase consumer trust and to provide them with recourse when they suspect that they are the victims of unfair discrimination, legislation should directly confront algorithmic transparency and burden of proof. Consumers cannot be expected to understand the mechanisms that determine what advertisements they are presented with or how automatic decisions are made about them. However, organizations should not be able to escape liability by claiming that they do not have access to the data or algorithm necessary to prove discrimination claims.

Enforcement

Panelists agreed that State Attorney Generals need to be able to enforce the law and that the FTC requires increased resources and enforcement powers. As Congress cannot anticipate every possible scenario, it is appropriate to give the FTC narrow rulemaking authority, the authority to fine for first offences, to be able to approve codes of conduct, and to clarify guidance on how to comply with the law on issues such as de-identification. The FTC needs vastly more resources to be able to accomplish this oversight and enforcement role. The jury is out as to whether Congress will pony up.

Sally Greenberg described the importance of also including an option for private parties to bring class-action suits. However, there was disagreement between panelists about whether individuals should be able to privately enforce their rights where the government lacks the resources or will to act. David Hoffman highlighted evidentiary problems associated with the difficulty in proving privacy harms. To better serve the public, he argued in favor of the creation of a uniform standard with strong protections.

Preemption of state laws 

The objective of creating a consistent federal standard was emphasized as a key driving factor for industry for the creation of a federal bill. Not including preemption of state law is a kind of “deal-breaker” for industry. They claim that complying with a patchwork of fifty different data breach notification standards is hard today. It was suggested that states could be given a window of five years with no preemption to allow them to adapt and innovate, after which time the situation could be reviewed. Or the reverse – preempt for five years and sunset the federal law. These suggestions both have merit, but in the end, answering the questions of preemption and private right of action remain to be seen.

Developing an approach towards consumer privacy and data security

Polly Turner-Ward

By NCL Google Public Policy Fellow Pollyanna Sanderson

This blog post is the first of a series of blogs offering a consumer perspective on developing an approach towards consumer privacy and data security.

For more than 20 years, Congressional inaction on privacy and data security has coincided with increased data breaches impacting millions of consumers. In the absence of Congressional action, states and the executive branch have increasingly stepped in. A key part of the White House’s response is the National Telecommunication and Information Administration (NTIA) September Request for Comment (RFC).

While a “Request for Comment” sounds incredibly wonky, it is a key part of the process that informs the government’s approach to consumer privacy. The NTIA’s process gathers input from interested stakeholders on ways to advance consumer privacy while protecting prosperity and innovation. Stakeholder responses provide a glimpse into where consensus and disagreements lie among consumer and industry players on key issues. We have read through the comments and in this series of blogs are pleased to offer a consumer perspective.

This first blog focuses on a fundamental aspect of any proposed approach to privacy and data security: the scope. Reflecting risks of big data classification and predictive analytics, one suggestion by the Center for Digital Democracy (CDD) was to frame the issues according to data processing outputs. This would cover inferences, decisions, and other data uses that undermine individual control and privacy. However, focusing on data inputs, there was consensus among many interested stakeholders that privacy legislation must cover “personal information.”

The Center for Democracy and Technology noted that personal information is an evolving concept, the scope of which is “unsettled…as a matter of law, policy, and technology.” Various legal definitions exist at the state, federal, and international level. The Federal Trade Commission’s (FTC) 2012 definition defines it as information capable of being associated with or reasonably linked or linkable to a consumer, household, or device. Subject to certain conditions, de-identified information is excluded from this definition. To help to address privacy concerns while enabling collection and use, many stakeholders agree that regulatory relief should be provided for effective de-identification techniques. This would incentivize the development and implementation of privacy-enhancing techniques and de-identification technologies such as differential privacy and encryption. Federal law to avoid classifying covered data in a binary way as personal or non-personal. An all-or-nothing approach requiring irreversible de-identification is a difficult or impossible standard.

In an attempt to recognize that identifiability rests on a spectrum, the EU’s General Data Protection Regulation (GDPR) excludes anonymized information and introduces the concept of pseudonymized data. These concepts demand federal consideration, having been introduced to United States law via the California Consumer Protection Act (CCPA). The law should clarify how it applies to aggregated, de-identified, pseudonymous, identifiable, and identified information. To be considered de-identified data subject to lower standards, data must not be linkable to an individual, risk of re-identification must be minimal, the entity must publicly commit not to attempt to re-identify the data, and effective legal, administrative, technical, and/or contractual controls must be applied to safeguard that commitment.

While de-identified and other anonymized data may be subject to lower privacy standards, they should not be removed from protection altogether. In their NTIA comment, the CDD highlights that third-party personal data, anonymized data, and other forms of non-personal data may be used to make sensitive inferences and to develop profiles. These could be used for purposes ranging from persuading voters to targeting advertisements. However, individual privacy rights may only be exercised after inferences or profiles have been applied at the individual level. Because profiles and inferences can be made without identifiability, this aspect of corporate data practice would therefore largely escape accountability if de-identified and other anonymized data were not subject to standards of some kind.

This loophole must be closed. Personal information should be broadly defined to address risks of re-identification and to capture evolving business practices that undermine privacy. While the GDPR does not include inferred information in its definition of personal information, inspiration could be taken from the definition of personal information given by the CCPA, which includes inferred information drawn from personal information and used to create consumer profiles.

Our next blog  will explore “developing an approach for handling privacy risks and harms.” In its request for comment, the NTIA established a risk and outcome-based approach towards consumer privacy as a high-level goal for federal action. However, within industry and society, there is a lack of consensus about what constitutes a privacy risk. Stay tuned for a deep dive into the key issues that arise.

The author completed her undergraduate degree in law at Queen Mary University of London and her Master of Laws at William & Mary. She has focused her career on privacy and data security.

BlackRock: Promoting shareholder activism – National Consumers League

By NCL Public Policy intern Melissa Cuddington

Many consumers think of money management companies, such as BlackRock Inc., Vanguard Group, and State Street Corp., to be solely interested in the finance market and ways to strengthen their investment portfolios. Turns out this isn’t entirely the case. 

The recent action of Laurence Fink, CEO of BlackRock Inc., calling on shareholders to better articulate long-term plans and spell out how their organizations can contribute to society in a positive manner, is a stellar example of a company promoting shareholder activism.

According to a Wall Street Journal article from earlier this year, Fink stated that BlackRock Inc. plans toover the next three yearsdouble the size of the team that engages with other companies regarding their societal impact. Fink also states that this team will be investigating corporate strategies that can be used when collaborating with investors and shareholders.

Fink states in his annual letter that investors must “understand the societal impact of your business, as well as the ways that broad structural trends—from slow wage growth to rising automation to climate change—affect your potential for growth.”

This statement by Fink caught NCL’s eye as a positive and productive move on the part of the finance industry. It is crucial that money management companies understand their societal impact and ways in which their investments affect structural trends—such as climate change and unemployment. We hope to see other money management companies follow suit.

Guest Blog: Fixing the Life Insurance Marketplace – National Consumers League

b.fetchel.jpgA version of this guest post was originally published in the National Underwriter. The views reflected here are not necessarily those of the NCL.

“The life insurance market is characterized not only by an absence of reliable price information, but also by the presence of deceptive price information…the deceptive sales practices found in the life insurance industry constitute a national scandal.” So testified Professor Joseph Belth, an expert on the life insurance industry, before Congress in 1973. Can this statement, from more than 40 years ago, still be as true today?  And is it possible for such deplorable industry practices to be occurring without being in the spotlight of public attention?

The short answers are yes. To this day the life insurance industry too often relies on inadequate product disclosure, misinformation, and fraudulent practices, thereby costing consumers billions of dollars annually. Industry executives have for years acknowledged that no one would buy many of their companies’ products if they were appropriately informed.

The free market economic system is built upon informed buyers making educated decisions. Yet so many life insurance industry chieftains who regularly sing the praise of our economic system fail to acknowledge that their businesses haven’t satisfied the system’s prerequisites or played by its rules.

Empirical proof of the life insurance market’s dysfunction is readily apparent by examining the very products life insurers and their agents sell. While a select few cash-value life insurance policies can provide excellent competitive value, perhaps 95% of such policies sold provide value no informed consumer would accept. This marketplace’s dearth of information also afflicts tens of millions of policyholders at annual renewal; if properly informed, millions of them currently could readily obtain much better value. Consumers of the industry’s other main products, annuities and long term care insurance, also face enormous disclosure-related problems.

The root of the age-old problem is the inadequate disclosure of information surrounding cash-value policies, such as whole life policies, where the annual cost is not the annual premium. Professor Belth and I have both long recommended disclosure about a policy’s annual costs and rate of return on its cash-values.  

The attached table of an actual insurance policy’s historical performance (see below) shows how this information on a policy’s annual costs and rates of return on its cash-values can be presented on a year-by-year basis and summarized over the duration with average or aggregate measures. Similar cost and rate information can be calculated on any and all prospective new and in-force policies via online consumer-friendly analytical tools. Understanding policies from this framework, and with solid knowledge of the differences between illustrated future values and actual future performance, enables consumers to assess the competitiveness of a policy’s costs and rates. For example, a healthy 40 year-old male can  compare his policy’s costs with benchmarks that are available in the marketplace and its rates of return with suitable alternative investments. 

A cash-value life insurance policy’s unique intrinsic economic advantages arise from its Congressionally-granted tax privileges, not its highly touted permanence; after all, a term policy can be converted or exchanged into a policy providing lifelong, permanent coverage. These tax privileges, which are given directly to policyholders, however, are not a basis for which insurers can charge consumers; no one pays thousands of dollars to set-up an individual retirement account (IRA). Consequently, when selling such cash-value policies as whole life agents routinely make assorted misrepresentations. Agents often misleadingly state: 1) that a whole life policyholder pays for a lifetime of costs upfront, and that doing such and owning his/her coverage is better than endlessly renting it; 2) that buying a whole life policy at a younger age locks in a lower level cost for life; and 3) that the annual costs of a whole life policy can actually decline as the insured ages because these policies can pay dividends. These three common agent statements, and myriad variations of such, are deceptive.

Regulations prohibit such misrepresentations, but they have never been enforced. These and other misrepresentations are all designed to distort a cash value policy’s fundamental difference. For agents, the essential difference between whole life and term insurance is the quantum difference in the sales commissions – up to 5-9 times larger on whole life policies than on term policies. No one familiar with the paramount role that compensation incentives tied to the origination of subprime mortgages and the repackaging of such default-inevitable, toxic securities played in creating the Great Recession can doubt the perniciousness of the life insurance industry’s age-old problematic sales practices.

A successful consumer-agent relationship can only be built on trust, so predicating it upon inadequate disclosure is inherently counter-productive to all. While inadequate disclosure appears to be in the insurers’ and agents’ interest, it actually has made consumers so leery of agents that the age-old distribution process is so terribly inefficient and ineffective. Americans’ under-insurance – having woefully less life insurance than needed or appropriate – reaches new records every year. Some insurers’ policy lapse rates raise fundamental questions regarding the products’ suitability that regulators have never examined. And, the facts that the typical life insurance agent sells less than one policy per week and that four out of five new sales recruits fail out of the business within a few years are further proof of this industry’s failed business approaches.

Given the nature of the problem, improved disclosure and publicity of such have always been known to be two indispensable parts of the inevitable solution. Contrary to general opinion, however, there is no need to wait to for this industry’s state regulators to act and mandate disclosure. The necessary disclosures, after all, are not proprietary or esoteric. As is shown in the table, life insurance policies, like an automobiles’ horsepower or MPG, can be disclosed, not only by the manufacturer, but by anyone with the necessary expertise and this information is now available online.

Without publicity though, this public good of disclosure remains undiscovered. Reform of the life insurance industry has always merely been a battle of wills. Reformers have had to confront industry, an uninterested or uninformed media, regulators not understanding their jobs or unwilling or unable to do them, and/or reformers’ own doubts about ever succeeding. Financial markets can be fixed when appropriate policy disclosure for consumers is heralded and becomes pervasive.

When will this information be publicly disseminated, so that everyone knows about it and can use it, thereby initiating the long-overdue repair of the life insurance marketplace? This disclosure-driven transformation will produce the myriad and well-documented benefits of genuine economic competition: consumers will obtain better value; insurers will improve the efficiency of their production processes; and agents will act and be seen as trustworthy professionals. Clearly, the sooner this time comes, the sooner Americans can start saving billions of dollars per year, the better for everyone.

 

Actual Historical Performance of a Whole Life Policy
$250,000 issued 20+ Years ago (in 1989) to a 45 Year Old Male, Best Health
*Annual Premium $5815 Paid All Years
** Notes below provide additional information

Age During Year

Insurance Death Benefit

Cash-Value

Total Annual Costs

Annual Dividend Rate

45

            251,425

  408

            5,444

10.00%

46

            253,954

 5,134

            1,556

10.00%

47

            256,890

10,188

            1,624

9.25%

48

            260,927

 15,823

            1,520

9.25%

49

            265,684

21,955

            1,403

8.50%

50

            271,380

28,709

            1,310

8.50%

51

            278,019

36,119

            1,235

8.50%

52

            285,871

44,344

            1,064

8.50%

53

            295,056

53,487

            998

8.80%

54

            305,332

63,521

            919

8.80%

55

            316,703

74,519

            844

8.80%

56

            328,867

86,417

            907

8.80%

57

            341,858

99,309

            787

8.60%

58

            354,658

112,782

            889

8.20%

59

            366,807

126,628

            1,022

7.70%

60

            378,831

141,112

            1,176

7.50%

61

            391,554

156,699

            1,160

7.50%

62

            404,738

173,322

            1,284

7.50%

63

            418,387

191,040

            1,425

7.50%

64

            429,215

207,946

            1,601

6.50%

 

 

 

Avg. Rate:

8.43%

 

**Insurance Death Benefit shows the amount the policyholder’s beneficiary would receive after his death
Cash-Value is the cash amount the insurer gives to the policyholder if he cancels his contract
Total Annual Costs show the amount expensed from policy premiums (and policy cash values if and when necessary) to pay for sales, claim, administrative, capital charges and any other miscellaneous costs, such as premium taxes.
Annual Dividend Rate is the rate earned by policyholder, net of investment management costs, on policy cash values, that is, values after costs.        

For More Information see this Table 2 of Policy Disclosure article.

The USDA plan to “modernize” poultry inspection is a step backwards – National Consumers League

The post originally appeared on scienceblogs.com. By Celeste Monforton, DrPH, MPH of George Washington University School of Public Health & Health Services 

The Obama Administration’s USDA continues to insist that their proposed rule to “modernize” poultry slaughter inspections will improve food safety. Just last week, Secretary Vilsack’s office said it is sticking with their plan, saying: “comprehensive effort to modernize poultry slaughter inspection in ways that will reduce the risk for American families.” For the last 18 months, however, the USDA Secretary has heard loud and clear that his agency’s proposal is certain to do much more harm than good.

Advocates for and experts on food safety, workers safety, consumers, animal rights, and even USDA’s own inspectors, have provided evidence of this during the agency’s public comment period. They’ve also follow-up with letters and petitions reiterating why the proposal should be scrapped. It’s fallen on Vilsack’s and his staff’s deaf ears. USDA’s response is particularly offensive because it contradicts one of President Obama’s declarations.   The President insists that his Administration wants input from the public. He may say his team wants input, but they’ve demonstrated no interest in being persuaded by it. And the evidence continues to pile up. The USDA’s proposed rule on a new poultry slaughter inspection process must be withdrawn.  The most recent evidence added to the hefty stack includes:

  • An investigation by the Government Accountability Office (GAO) concluding that USDA does not have evidence from its pilot project to support its proposed new inspection process. GAO found problematic that USDA: “will not complete another evaluation before it issues a final rule.” That’s the final rule that USDA insists it will issue very soon.
  • Legislation introduced in September 2013 by Senator Kirsten Gillibrand (D-NY) would halt USDA’s action. Responding to the GAO report, the Senator wants to ensure USDA gathers the necessary evidence to justify its assertions that the new system will improve food safety.
  • A coalition of 16 civil rights, worker safety, and faith groups petitioned USDA (and the Secretary of Labor) to withdraw the proposed rule, and adopt a rule to protect poultry- and meat-processing workers from the extreme production line speeds which injury and disable them.  These workers—many of them Latino and African-American, and female—are vulnerable to employer abuse and already experience severe injury and disability because of their work.
  • And, food safety experts persist in assembling the most current evidence on defects in the USDA’s pilot project and proposed rule. As new evidence emerges, they provide it to USDA. They have repeatedly asked USDA Secretary Vilsack to revoke the the equivalency determinations because the HIMP model in swine slaughter is flawed. The most recent letter informed USDA (just in case they didn’t already know) that the European Union seems to have rejected the Australian privatized meat inspection model. As Food & Water Watch explained, the EU’s concern is the

“apparent conflict of interest of having company-paid employees inspect meat for safety and wholesomeness. In its zeal to privatize inspection here in the U.S., USDA’s Food Safety Inspection Services may have created a trade crisis by hastily approving its ill-conceived program abroad. It’s time to revoke those equivalency determinations before there is a major international food safety incident.” All of this—combined with the overwhelming rejection of the USDA approach in comments submitted to the agency during the formal public comment period—should be more than enough for the agency to scrap their plan. But there’s more. Icing on the Cake The icing on the cake is stellar reporting by the Washington Post’s Kimberly Kindy. For the last seven months she’s investigated the potential impact of USDA’s proposed changes to poultry slaughter inspection. In AprilKindy wrote about the death of USDA poultry inspector Jose Navarro. The 37 year-old father died from a pulmonary hemorrhage likely related to exposure to chemicals used to disinfect poultry. Navarro’s assignment was inspecting poultry at Murray’s Chicken in upstate New York. Her investigation led to a private report provided by USDA to the House Appropriations Committee. The agency acknowledged that in plants which have already accelerated line speeds, workers have been exposed to larger amounts of chemical disinfecting agents. “The use of powerful antimicrobial chemicals has increased in order to decrease microbial loads on carcasses.” Increasing production line speeds is exactly what USDA is proposing to do. The chemical agents in which the poultry soaks, poses a serious risk of harm to USDA inspectors, as well as the thousands of workers employed in these plants. Jose Navarro’s death is the gravest example of that point. In SeptemberKindy reported on USDA’s failure to control contaminated meat produced at plants that are using the agency’s “modernized” inspection system from reaching consumers. In exchange for adopting the new system, poultry and meat producers can substantially increase lines speeds, use employees to inspect the product throughout the process (which means fewer USDA inspectors) and come up with their own scheme to identify contaminated meat and poultry. The system has been adopted by some oversees producers whose meat is imported to the U.S. Kindy interviewed members of USDA’s own scientific advisory committee. Commenting on the USDA’s pilot and plans to implement it nationwide, one committee member told Kindy: “We should not be putting it out there, saying it is okay for other countries to use, when it has so many flaws and when contaminated meat is coming in.” Last week, Kindy added to her series on USDA’s plan. She reported that the proposed increase in line speed will not only be a danger to workers, lead to increase use of chemicals, and could allow contaminated meat into the food supply, but that the “USDA plan to speed up poultry-processing lines could increase risk of bird abuse.”  [This next part is not for the faint of heart.] “Nearly 1 million chickens and turkeys are unintentionally boiled alive each year in U.S. slaughterhouses, often because fast-moving lines fail to kill the birds before they are dropped into scalding water, Agriculture Department records show.” USDA reacted to Kindy’s Oct 29 story with a post on the agency’s blog. They insist their proposal is just hunky-dory, adding “Experts agree that it would significantly reduce foodborne illnesses – reducing dangerous pathogens like Salmonella to protect American families.  Improving America’s food inspection system will do just that, and USDA is committed to undertaking this effort in a way that ensures even stronger humane handling measures in the future.” As far as I can tell, the “experts who are agreeing” are two individuals on whom the USDA relies. One is Professor Billy Hargis from the University of Arkansas. He is the Sustainable Poultry Health Chair, and endowed position, funded in part, by the Tyson Family (Tyson, as in the mammoth poultry company.)  The other expert is Douglas Fulnechek, DVM, a manager and veterinarian at USDA. Personally, I don’t consider either unbaised experts.  In contrast, many public health experts, who have no financial or professional stake in the outcome, submitted scads of evidence to USDA on the likelihood of grave harm should its proposal be adopted. From contaminated meat and crippled workers, to toxic chemicals and tortured chickens, surely the White House will ask Secretary Vilsack to withdraw this ill-conceived rule. If not, we’ll be asking the Obama Administration, which side are you on?  I take that back, we’ll know which side they’re on.

Free webinar: Improving communication between patients and health care professionals – National Consumers League

Dr. Ira Wilson of Brown University will lead the webinar “Medication Adherence in Practice” on November 19. Three out of four Americans do not take their medications as prescribed. Open communication between health care professionals and their patients can be a powerful tool for improving rates of medication adherence.

Health care professionals including nurses, doctors, and pharmacists can inform patients about the importance of taking their medicines as directed in order to improve overall health outcomes. Often, it is difficult to know the right questions to ask for both the patient and health care professional.

NCL’s Script Your Future campaign is holding its first-ever free webinar for health care professionals to learn how to talk with patients about taking medication as directed.  This webinar, on November 19 at 12noon Eastern, is a part of ongoing efforts to provide resources to both patients and health care professionals about medication adherence and how to improve communication in the health care setting. There are many reasons why people don’t take their medicine as directed, including forgetfulness, side effects, not sure they need medicine, and cost. Having that conversation to understand the patients’ concerns can help health care professionals provide better care.

Featuring Dr. Ira Wilson from Brown University, the webinar will present health care professionals with tools to communicate effectively with patients. Dr. Wilson will include real-world examples and solutions that he has developed over the years to establish trust with his patients and improve care.

This webinar is a must-attend for any professional who is looking to improve their skills.Join this free webinar today by registering here. Bring your questions to this exciting and interactive event! What: Webinar for health care professionals – doctors, nurse practitioners, pharmacists, nurses, etc. When: Tuesday, November 19, 12noon – 1 pm Eastern Contact Ayanna Johnson at ayannaj@nclnet.org with any questions. For more information about the Script Your Future campaign, visit www.ScriptYourFuture.org.