Valuable public health lessons from COVID-19

The lessons of a crisis are of little use if they are not kept in mind after it has passed.

By Robert I. Field

Never let a pandemic go to waste. You might learn something.

A month, ago how much did you know about self-quarantine, social distancing, contact tracing, flattening the curve, or disease testing kits? Now, most of us know that they may save our life – and the lives of millions of others.

A month ago, could you name the director of the National Institute of Allergy and Infectious Diseases? Now, this government official, Dr. Anthony Fauci, holds the entire country’s welfare in his hands.

A month ago, did you think that hand sanitizer, rubbing alcohol, surgical masks – and toilet paper – would be among the most sought-after consumer products?

We have quickly learned a lot about an essential pillar of our country’s well-being: public health. It is more than the city official who closes a local restaurant or the announcer on a public service video who scolds us about wearing a seat belt. Like the security suite running in the background on your computer, it is the often-hidden support that responds to threats before the entire system crashes.

But if we don’t retain our newly gained knowledge, we will be no better prepared when the next threat emerges. Amnesia can kill.

Here are five key lessons from COVID-19 for all of us to bear in mind in the years ahead.

1.      You never know when you, and everyone around you, will need public health.

Public health threats don’t usually announce themselves in advance, and they can worsen very quickly. The first case of COVID-19 occurred in Wuhan, China last November. In December, hospitals there were treating dozens of cases. In January, the first cases were confirmed in United States and several other countries. Public health infrastructure needs to be there to respond quickly. You don’t wait to buy an umbrella until after it begins to rain.

2.      You don’t hear more about public health because it has been so successful.

Remember when epidemics of polio, smallpox, yellow fever and cholera threatened whole cities? You almost certainly don’t because measures like vaccination, clean drinking water, sanitation and pest control conquered them in this country decades ago, probably before you were born.

3.      Public health is most effective when it is global.

Infectious diseases don’t stop at national borders and never have since the dawn of civilization. It is only through international cooperation that we can hope to control their spread, something that has been haphazard this time. Almost no nation on Earth has been spared from COVID-19. We rely on global monitoring to spot emerging flu strains each year so scientists can develop vaccines before they arrive. The more we cooperate globally, the better protected we are.

4.      Public health transparency is crucial, and a free press is essential to providing it.

Chinese officials kept the public in the dark about COVID-19 until late January, while people moved freely in and out of Wuhan. China lacks a free press to spread the word. Had the Chinese public learned about the outbreak sooner, we might not be facing the current crisis. And transparency builds public trust, without which the current pandemic responses would not be possible.

5.      Our whole economy depends on public health.

Take a look at the stock market. Need I say more?

Those who cannot remember the past are condemned to repeat it, as the saying goes. The lessons of a crisis are of little use if they are not kept in mind after it has passed. COVID-19 is showing us how important it is to keep the security suite running. Even when we don’t see it, we continually rely on public health security so that the threats we don’t yet see are more likely to stay that way.

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Robert I. Field is professor of law and public health at Drexel University. He is also founder, editor and lead writer of the Health Cents blog on Inquirer.com.

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This blog post first appeared as an op-ed in the Philadelphia Inquirer.

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Legal Epidemiology Faith Khalik Legal Epidemiology Faith Khalik

Public health leaders post open letter to Pence on coronavirus response

This week, public health and legal experts posted an open letter to Vice President Mike Pence and other government leaders detailing the necessary steps for a successful response to the COVID-19 pandemic.

This week, public health and legal experts posted an open letter to government officials, including the leader of the administration’s coronavirus task force, Vice President Mike Pence, detailing the necessary steps for a successful response to the COVID-19 pandemic.

The letter, signed by 488 public health leaders and 14 organizations, states that whether the response is able to effectively diminish the scope and impact of the coronavirus depends on “whether there is adequate funding and support for the response; fair and effective management of surging health care demand; careful and evidence-based mitigation of public fear; and necessary support and resources for fair and effective infection control.”

Read the full letter here.

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Fed Legislation/Reg Faith Khalik Fed Legislation/Reg Faith Khalik

2020 Presidential Candidates: Policies for Addressing Prescription Drug Pricing

This post is third in a series aimed at identifying and exploring some of the public health issues and policies under consideration by candidates in the 2020 Presidential Election.

This post is third in a series aimed at identifying and exploring some of the public health issues and policies under consideration by candidates in the 2020 Presidential Election.

The goal of this series is to provide a deeper look at the ways in which candidates may or may not be including a public health framework in their healthcare reform policies, and encourage candidates to thoughtfully and purposefully develop nuanced, evidence-based, impactful policies. We also hope to inform the public as they continue to evaluate each candidate’s efforts to articulate plans that address healthcare and public health challenges in the U.S. Our goal is not endorse a particular candidate or political party; rather, our goal, as always, is to research, analyze, inform, and equip people with the knowledge they need to be engaged and thoughtful members of their communities and this nation.

Many of the policies championed by the candidates vying for the 2020 Democratic nomination have centered on healthcare reform. Particular emphasis has been placed on the need to address the immense financial burden faced by Americans as they try to meet their more basic medical needs. One need look no further than bankruptcy courts to understand the impact medical costs, and resulting debt, has on Americans. Medical debt is the greatest cause of bankruptcy in the United States, and some choose to forego necessary medical care. One in four Americans struggle to afford their medications, and three in ten skip doses or forgo refills due to costs. Many diabetics are forced to ration their insulin and elders are reducing their dosage to stretch a prescription. The pharmaceutical industry is one particularly problematic element of the American healthcare system that contributes greatly to the expenses levied on patients, as the industry itself comprises the most profitable companies in the entire healthcare system. This wealth is widely seen as having accrued at the expense of the American citizen.

In 2017 the United States spent $1,220 per person on pharmaceuticals. Americans paid, on average, $600 more each year for prescription drugs than residents of comparable high-income nations. Pharmaceutical companies are continuously able to arbitrarily hike prices, such as when Turing Pharmaceuticals raised the HIV medication Daraprim from $13.50 to $750 per tablet.

We reviewed the various prescription drug pricing policies of each candidates, all of which fall into one of the following categories:

  • Increase regulation of the pharmaceutical industry

  • Grant the Department of Health and Human Services (HHS) more power to engage with the pharmaceutical industry 

  • Cap out-of-pocket drug costs

  • Expand engagement with international markets 

INCREASE REGULATION OF THE PHARMACEUTICAL INDUSTRY

Revoke Patents from “Worst Offenders”:

Buttigieg and Warren have proposed using provisions from the Bayh-Dole Act of 1980 to revoke patents from companies that price their drugs unaffordably, thus harming patients. Under the Bayh-Dole Act, federal agencies have “march-in rights” that enable them to require patent holders who have received federal funds to grant licenses to third parties. There have been five march-in petitions since 1997 (all denied by NIH), including one signed by 51 Congressional Democrats in 2017

Increase Annual Branded Prescription Drug Fee:

Buttigieg has proposed increasing the Branded Prescription Drug Fee. The Branded Prescription Drug Fee Program (BPD) was enacted under the Affordable Care Act. Under the program, drug manufacturers and importers must pay a fee based on their share of branded prescription drug sales to government programs, including Medicare, Medicaid, and the VA. 

Charge Rebate for Prices Increasing Faster than Inflation:

Buttigieg and Biden have suggested that pharmaceutical companies pay a rebate for drugs with prices increasing faster than inflation. Buttigieg proposes withholding government payment until companies comply with the rebate. Biden proposes prohibiting companies from participating in Medicare and public option until companies comply with the rebate. 

Combat Anti-Competitive Practices:

Buttigieg, Warren, and Klobuchar have proposed measures to combat anti-competitive practices within the pharmaceutical industry, such as “pay-for-delay” deals, which occur when pharmaceutical companies compensate competitors to delay marketing their generic drugs. When generic manufacturers challenge brand-name manufacturers’ patents, the brand-name company will sue the generic company for patent infringement. The two companies will settle with a “reverse payment agreement,” where the suing brand-name company actually pays the generic company, and the generic company agrees to delay marketing their product until a specified date. According to the Federal Trade Commission, these deals result in consumers and taxpayers paying an additional $3.5 billion per year through higher drug costs. 

Warren says her administration will pursue antitrust action against companies such as AbbVie, who entered into a pay-for-delay settlement in 2019 to prevent generic competition for its drug Humira. Klobuchar sponsors the Preserve Access to Affordable Generics and Biosimilars Act, which prohibits pay-for-delay deals. Buttigieg says he supports the Protecting Consumer Access to Generic Drugs Act, which would make pay-for-delay deals illegal. 

End Tax Deductions for Prescription Drug Adverts:

Sanders, Warren, Biden, Klobuchar, and Steyer propose ending tax deductions for prescription drug advertisements. Under current law, pharmaceutical companies can deduct their advertisement costs from federal taxes. In 2016, these expenses reached $6 billion. Sanders, Warren, and Klobuchar cosponsor the End Taxpayer Subsidies for Drug Ads Act

Improve Transparency in Drug Pricing:

Buttigieg has proposed several measures to increase drug price transparency. This includes requiring pharmaceutical companies that sell prescription drugs to Medicaid, Medicare, and the public option to report information on sales volume, price, discounts, rebates, promotion, manufacturing costs, and R&D spending to the federal government. Additionally, companies would be required to report drug ingredient sources and manufacturing location on the drug label. Finally, pharmacy benefit managers (PBMs) that work with Medicaid, Medicare, and the public option would be required to report sales information, pricing, and rebates received to the federal government. 

Limit Brand-Name Patents

Bloomberg has proposed limiting brand-name drug companies to one 20 year patent. He would also require drug companies that use National Institutes of Health (NIH) IP to make a commercial drug product to pay royalties to NIH, with revenue going to fund additional research and lower Medicare drug costs.

Eliminate Drug Manufacturer Payments to Pharmacy Benefit Managers

Bloomberg has proposed eliminating drug company rebates to PBMs, companies that administer prescription drug benefits on behalf of health insurers. PBM rebates were singled out by President Trump as a cause of high prescription costs; however, he withdrew a proposal to eliminate such rebates for Medicaid and Medicare in July 2019. PBMs receive larger rebates for more expensive drugs, giving them an incentive to favor high-priced drugs. However, a 2019 GAO report found that “virtually all (99.6%) prescription drug rebates negotiated by PBMs with drug manufacturers in Medicare Part D are passed through to drug plan sponsors and used to lower costs for Medicare beneficiaries.”

CAP OUT-OF-POCKET DRUG COSTS

Cap Out-of-Pocket Drug Costs

Sanders, Buttigieg, Warren, and Bloomberg have proposed capping out-of-pocket drug costs. Sanders and Warren propose a cap for everyone, while Buttigieg proposes a cap for public option, Medicaid, and Medicare Part D recipients. Bloomberg also  proposes a cap for Medicare Part D recipients

Under Sanders’ Medicare for All plan, everyone’s out-of-pocket drug costs would be capped at $200 per year. Individuals or families with an income under 200% of the federal poverty level would not pay anything. Warren’s Medicare for All plan says there would be no cost sharing at all. 

Buttigieg would cap out-of-pocket drug costs at $200 per month and $2400 per year for seniors on Medicare, with lower caps for seniors with lower incomes. Those on public option would be capped at $250 per month. Co-payments for generic drugs would be $0 for those on Medicaid, and for low-income individuals on public option. Bloomberg would cap out-of-pocket drug spending for Medicare beneficiaries at $2000 per year. 

GRANT HHS MORE AUTHORITY TO ENGAGE WITH THE PHARMACEUTICAL MARKET

Empower the Federal Government to Negotiate Drug Prices:

Under the Medicare Modernization Act of 2003 (MMA), which established the Medicare Part D benefit, the HHS Secretary “1) may not interfere with the negotiations between drug manufacturers and pharmacies and PDP sponsors; and 2) may not require a particular formulary or institute a price structure for the reimbursement of covered part D drugs.” This section of the bill, known as the “noninterference clause,” prohibits the government from negotiating Medicare drug prices. Among voters, empowering this negotiation is a fairly uncontroversial measure; overall, 88% of Americans, including 92% of Democrats and 85% of Republicans, favor allowing the federal government to negotiate with drug companies for Medicare beneficiaries. Even Donald Trump campaigned on allowing Medicare to negotiate prices, later breaking from that strategy in 2018.

Currently, Medicaid and the Veterans Benefits Administration (VBA) are allowed to negotiate; Medicare pays 73% more than Medicaid and 80% more than the VBA on brand name drugs.  In December, the House passed a bill allowing the government to negotiate on Medicare prices.

All of the candidates have expressed support for allowing the federal government to negotiate on behalf of Medicare for lower drug prices. 

Empower the Federal Government to Manufacture Generic Drugs:

Under Warren’s Affordable Drug Manufacturing Act, HHS would be allowed to manufacture generic drugs when no company is manufacturing a drug, when only one or two companies manufacture it and the price has spiked, when the drug is in shortage, or when a medicine listed as “essential” by the WHO faces limited competition and high prices.

EXPAND ENGAGEMENT WITH INTERNATIONAL MARKETS

Permit Purchase of Low-Cost Prescription Drugs from Other Countries:

All of the candidates, except for Buttigieg, have expressed support for allowing the purchase of prescription drugs from other countries. 

Use International Prices to Benchmark Prices in the US

Sanders, Biden, and Steyer have suggested benchmarking prescription drug prices in the US against international prices in order to control costs. Sanders has suggested pegging US drug prices to the median drug prices in Canada, the UK, France, Germany and Japan. Biden has suggested using this method only in the case of new specialty drugs introduced without competition; an independent review board established by HHS would determine a reasonable price based on the average price in other countries. Medicare and the public option would pay this rate, and private plans in the individual marketplace would be able to access a similar rate. Steyer has not released any further details beyond stating that prescription drug prices will be benchmarked against international standards and price-capped. 

All candidate stances were sourced from their official campaign websites, accessible below:

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Gun Violence Faith Khalik Gun Violence Faith Khalik

2020 Presidential Candidates: Policies for Addressing Gun Violence

This post is second in a series aimed at identifying and exploring some of the public health issues and policies under consideration by candidates in the 2020 Presidential Election.

This post is second in a series aimed at identifying and exploring some of the public health issues and policies under consideration by candidates in the 2020 Presidential Election.

The goal of this series is to provide a deeper look at the ways in which candidates may or may not be including a public health framework in their healthcare reform policies, and encourage candidates to thoughtfully and purposefully develop nuanced, evidence-based, impactful policies. We also hope to inform the public as they continue to evaluate each candidate’s efforts to articulate plans that address healthcare and public health challenges in the U.S. Our goal is not endorse a particular candidate or political party; rather, our goal, as always, is to research, analyze, inform, and equip people with the knowledge they need to be engaged and thoughtful members of their communities and this nation.

By Connor Holmes

By many metrics, gun violence is an epidemic in the United States of America. With approximately 400 million firearms across the nation, in 2017 alone nearly 40,000 people were killed by guns. The American firearm homicide rate is 25 times that of comparable high-income nations, and approximately 21 children are shot every day. While mass public shootings, subsequent media coverage, and the inevitable political debates that later arise are emblazoned in the forefront of the American psyche, acts of gun violence occur in the everyday lives of many Americans, with firearm injury and death disproportionately impacting urban communities and communities of color. These alarming statistics that tell the story of gun violence in this country are frequently cited by many of the candidates vying for the Democratic presidential nomination in 2020.

Below I have aimed to synthesize the major policies put forward this campaign season by the Democratic candidates which intend to curb this epidemic, alongside the finer details which distinguish one candidate’s stance from another. For the sake of this analysis the individuals considered to be in competition for the 2020 Democratic Presidential candidacy are as follows: Senator Bernie Sanders, Senator Elizabeth Warren, former Vice President Joe Biden, Mayor Pete Buttigieg, Senator Amy Klobuchar, Tom Steyer, and former Mayor Michael Bloomberg.

BACKGROUND CHECK REFORM

Universal Background Checks:

While the government currently operates a background check system at the federal level, managed by the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) in conjunction with the Federal Investigation Bureau (FBI), many of the candidates find the scope of this system insufficient. Approximately 1 in 5 firearms are sold or transfer ownership without the processing of a background check. Many firearm sales occurring at gun shows, over the internet, and privately between individuals beyond the confines of a registered business escape registration with the federal system, and therefore purchasers are not subject to federal approval.

All candidates support the expansion of the federal background check system to include private sales of firearms made at gun shows and online, excluding only the most intimate exchange of guns such as gifts between family members or close friends.

The “Boyfriend Loophole”:

What is commonly referred to as the “boyfriend loophole” is a gap in current legislation that bars those convicted of domestic violence from purchasing a firearm, but only if the individual is married to, lives with, or has children with the victim. Consequently, Warren, Biden, Buttigieg, Klobuchar, Steyer, and Bloomberg have committed to closing this loophole by redefining intimate partner violence under this law to include anyone with a conviction of assault or stalking regardless of relationship with the victim. Such reform would entail notification of state and federal authorities of background checks failed on the grounds of a history of domestic abuse, thus unarming domestic abusers.

The “Charleston Loophole”:

The “Charleston loophole” refers to legislation which gives the FBI a maximum of three days to perform a background check, after which a firearm sale may proceed at the discretion of the distributer. All candidates except Sanders have explicitly supported removing such a time limit.


LICENSURE AND REGULATION

Firearm Licensure System:

There is a strong desire amongst the candidates to establish a firearms licensing system, in which obtaining a license following a thorough criminal background check is required to purchase and own a gun. However, the candidates do differ in regards to the level at which such a system would be implemented and who would be tasked with managing it.

Warren proposes a licensing system that is created and operated at the federal level. Buttigieg and Steyer also support the creation of a federal licensing system, but defer to the states for implementation and management. In addition, Buttigieg specifically calls for licenses to be required to purchase ammunition.

Conversely, Biden supports a more state-centric approach in which the federal government financially incentivizes the establishment of licensing systems at the individual state level via the provision of grants. Steyer and Bloomberg additionally express support for ensuring the safe storage of firearms

Neither Sanders nor Klobuchar have outlined explicit policy proposals regarding gun licensing.

Extreme Risk Protection:

Extreme risk protection laws (also known as “red flag laws”) enable people to petition judges for an Extreme Risk Protection Order (ERPO), which temporarily bans an individual who is deemed in crisis of hurting themselves or others from acquiring a firearm. Depending on the state, the people who can request an ERPO can be broad enough to include an individual’s coworkers, or narrow enough to include only law enforcement. All of the candidates explicitly support the creation of such legislation. Warren, Buttigieg, and Bloomberg seek to enact such a law at the federal level, with Warren suggesting Congress provide grants to incentivize the further creation of similar laws at the state level. Conversely, Biden and Klobuchar intend to rely entirely on this latter technique of financial incentivization to states, allowing each state to craft their own laws without an overarching federal requirement. Sanders and Steyer, while in support of such extreme risk protection legislation, have not stipulated the logistics of how these laws would be implemented and enforced.

Restrictions on Age and Frequency of Purchase:

Warren and Bloomberg propose federal policy to mandate a minimum age of 21 to purchase any firearm, with Klobuchar supporting this adjustment of age limitations solely in regard to the purchase of assault weapons. In addition, Warren, citing that 1 of 4 firearms involved in a crime are acquired as part of a bulk purchase, proposes a federal limit of one gun purchased per month. 

Federal Ban on Assault Weapons:

All candidates support a ban on assault weapons and related paraphernalia, in line with the assault weapons ban of 1994 which was allowed to expire ten years later without renewal. The candidates unanimously call for a Congressional ban on the production and sale of assault weapons and high-capacity ammunition magazines. In addition, Warren specifies regulating accessories such as silencers and trigger cranks that serve only to increase the lethality of a weapon. Warren and Biden also propose banning the importation of such weapons, with Biden specifying legislation to halt gun manufacturers from circumventing legislation by altering products without decreasing the lethality of the weapon. In addition, all candidates support the prohibition of 3-D printed and self-assembled firearms and bump stocks. 

Refuting the concern that such a ban would entail the seizure of weapons, Sanders, Warren, Biden, and Steyer specify that the policy would call for owners of existing assault weapons to undergo a federal background check and register their firearms under the National Firearms Act. In addition, a federal buyback program would be implemented to remove as many weapons as possible from the American public.

Anti-Trafficking and Enforcement of Firearm Legislation:

Overall, the candidates call for a stronger enforcement of extant and proposed legislation aiming to control the access of firearms in the United States. Sanders, Warren, Biden, and Bloomberg place distinct emphasis on curbing “straw purchases” in which individuals able to pass a background check purchase firearms for criminals, with these candidates committing to direct law enforcement to target this practice. Further, Biden, Buttigieg, and Bloomberg highlight the need for law enforcement to follow up with weapons that are reported lost or stolen. Steyer has proposed the creation of discrete Office of Gun Violence Prevention to coordinate control and prevention measures at the federal level between the ATF, FBI, and other bureaus. Likewise, Bloomberg supports appointing an designated official within the White House cabinet to coordinate and oversee all gun violence prevention activities.


LEGISLATIVE REFORM

Combat the Gun Lobby:

Sanders, Warren, Buttigieg, and Steyer have committed to ending the immense lobbying power of the NRA and other promoters of firearms that consistently obstruct the passage of common sense gun violence prevention legislation. Buttigieg, Steyer, and Bloomberg specifically have proposed to repeal the Protection of Lawful Commerce in Arms Act, which shields the firearms industry from liability for their role in facilitating gun violence.

Taxation of Firearm Sales:

Senator Warren specifically endorses raising taxes on firearm manufacturers and importers (30% on guns, 50% on ammunitions) to financially disincentivize the purchase of weapons. She proposes using this money to fund federal programs for gun violence prevention and law enforcement.


A PUBLIC HEALTH APPROACH

Public Health Research Funding:

Following vigorous National Rifle Association (NRA) lobbying efforts, Congress has continuously cut funding and limited the scope of inquiry for federal research investigating gun violence as a public health problem. All candidates support allocating significant funds (with Biden and Buttigieg committing a minimum of $50 million) to such research headed by the Department of Health and Human Services and its subsidiaries, the National Institutes of Health and the Centers for Disease Control and Prevention.

Community-Based Prevention Efforts:

Biden, Steyer, and Bloomberg expressly commit to allocate funding for community-based gun violence and firearm safety initiatives for prevention.

Remove Firearms from Educational Settings:

Warren, Buttigieg, and Bloomberg commit to opposing legislation permitting guns on educational campuses by non-law enforcement individuals. Biden and Klobuchar distinctly intend to block federal funding to train and arm teachers with firearms.

Mental Health and Gun Violence:

Biden and Steyer commit to promoting mental health services, both in order to prevent gun violence and to support those impacted by it.

Explore Safe-Gun Technology:

Bloomberg proposes regulating guns under the Consumer Product Safety Commission to facilitate the development of novel safety technologies.


All candidate stances were sourced from their official campaign websites, accessible below:

Connor is a third year undergraduate student at Northeastern University pursuing a degree in health science, with a concentration in global health. His primary interests relate to how health systems and policy can be organized to promote equity and justice in healthcare. This is his third semester working with PHLW.

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Fed Legislation/Reg, Opioid/Substance Faith Khalik Fed Legislation/Reg, Opioid/Substance Faith Khalik

2020 Presidential Candidates: Policies for Addressing the Opioid Overdose Crisis.

Each day, over 130 people die from opioid-related overdoses. This includes both prescription and illicit opioids. The National Institute on Drug Abuse attributes the opioid overdose crisis to unscrupulous pharmaceutical companies, who misled healthcare providers to believe opioid pain relievers were not addictive. Other researchers, while agreeing that increased drug supply was an important factor, argue that economic and social issues fueled the crisis, viewing the issue through the lens of a structural and social determinants of health framework.   

This post is first in a series aimed at identifying and exploring some of the public health issues and policies under consideration by candidates in the 2020 Presidential Election.

The goal of this series is to provide a deeper look at the ways in which candidates may or may not be including a public health framework in their healthcare reform policies, and encourage candidates to thoughtfully and purposefully develop nuanced, evidence-based, impactful policies. We also hope to inform the public as they continue to evaluate each candidate’s efforts to articulate plans that address healthcare and public health challenges in the U.S. Our goal is not endorse a particular candidate or political party; rather, our goal, as always, is to research, analyze, inform, and equip people with the knowledge they need to be engaged and thoughtful members of their communities and this nation.

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Each day, over 130 people die from opioid-related overdoses. This includes both prescription and illicit opioids. The National Institute on Drug Abuse attributes the opioid overdose crisis to unscrupulous pharmaceutical companies, who misled healthcare providers to believe opioid pain relievers were not addictive. Other researchers, while agreeing that increased drug supply was an important factor, argue that economic and social issues fueled the crisis, viewing the issue through the lens of a structural and social determinants of health framework.   

Public health experts and practitioners are increasingly pursuing support for and implementation of evidence-based harm reduction policies and programs to reduce harmful outcomes related to substance use disorders (SUD) and opioid use disorders (OUD). Our colleagues at the Health in Justice Action Lab (HIJAL) have identified a series of proven hard reduction programs. Below we offer a description for a few such programs and identify which of the 2020 Democratic Presidential Candidates support each program:

  • Safe injection facilities

  • Buprenorphine deregulation

  • Increased access to SUD treatment in prisons and jails

  • Decriminalization of opiates for personal use

Safe injection facilities

Safe injection facilities, also known as supervised consumption services (SCS), are legal facilities in which people can bring in and consume illicit drugs under the supervision of trained staff. The facilities provide clients with sterile injection supplies and a safe place to consume drugs, as staff members monitor for overdose and provide first aid as needed. Additionally, staff members are available to provide clients with referrals to drug treatment and other support programs. Although many studies have identified myriad public health benefits of safe injection sites, they remain controversial. Safe injection sites exist around the world, but due to legal issues (and specifically the Controlled Substance Act), not yet in the United States. However, that may be changing soon; a federal judge recently ruled that the Controlled Substance Act does not apply to Safehouse, a Philadelphia group seeking to open a safe injection facility

Candidates who have expressed support for safe injection facilities:


Buprenorphine deregulation

Buprenorphine is an opioid partial agonist used in treating opioid use disorder (OUD). Under the Drug Addiction Treatment Act of 2000, prescribers must complete an approved training, attest to their referral capacity, and submit an application to SAMHSA in order to receive what is known as an “X-waiver.” As noted by Kevin Fiscella et al, “X-waivered prescribers face heightened scrutiny by federal and state law enforcement officials, including periodic audits that are intended to minimize diversion and misuse.” Fiscella articulates four reasons for deregulating buprenorphine:

“First, buprenorphine’s comparative safety undermines a critical rationale for regulation. Buprenorphine, regardless of prescribing intent, is safer than commonly prescribed full-opioid agonists.

Second, deregulation would improve access to buprenorphine during the opioid national emergency. Despite promotion and training initiatives by SAMHSA and legislation that has expanded patient limits and waivers to nurse practitioners and physician assistants, access to buprenorphine has not kept pace with the current epidemic, particularly in rural communities.

Third, buprenorphine regulation is premised on the faulty assumption that buprenorphine diversion is driven by a desire to “get high.” Yet, buprenorphine obtained illicitly is mostly used for self-medication to relieve withdrawal symptoms rather than for euphoria… This suggests that regulations constraining access to buprenorphine may paradoxically contribute to a market for illicit buprenorphine among those who seek treatment.

Lastly, deregulation could help integrate opioid disorder treatment into primary care. Regulations reinforce the stigma surrounding buprenorphine prescribers and patients who receive it while constraining access and discouraging patient engagement and retention in treatment.”

Candidates who have expressed support for buprenorphine deregulation:

Increased access to SUD treatment in prisons and jails

A federal report found that 58% of people in prison and 63% of people in jail suffer from drug use disorders (SUD) based on criteria from the Diagnostic and Statistical Manual of Mental Disorders. However, only 28% of people in prison who met this criteria and 22% of people in jail participated in any type of SUD treatment.

Candidates who have expressed support for increased access to SUD treatment in prisons and jails:

Decriminalization of opiates for personal use

Some advocates have proposed decriminalization as a measure to improve public health. The Drug Policy Alliance lists several benefits of decriminalization on their website:

 “Removing criminal penalties for drug possession and low-level sales would:

  • Save money by reducing prison and especially jail costs and population size

  • Free up law enforcement resources to be used in more appropriate ways

  • Prioritize health and safety over punishment for people who use drugs

  • Reduce the stigma associated with drug use so that problematic drug users are encouraged to come out of the shadows and seek treatment and other support

  • Remove barriers to evidence-based harm reduction practices such as drug checking, heroin-assisted treatment, and medical marijuana.”

Candidates who have expressed support for decriminalization of opiates for personal use:

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Fed Legislation/Reg Jennifer Huer Fed Legislation/Reg Jennifer Huer

Healthcare and the 2020 Presidential Election blog series

U.S. Healthcare reform remains a central issue in any policy debate, especially during an election year, such that many candidates in the 2020 Presidential Election have indicated healthcare as one of their “signature issues.” To better understand where each candidate stands on issues, Public Health Law Watch is launching a new blog series aimed at identifying and exploring some of the public health issues and policies under consideration by candidates.

U.S. Healthcare reform remains a central issue in any policy debate, especially during an election year, such that many candidates in the 2020 Presidential Election have indicated healthcare as one of their “signature issues.” To better understand where each candidate stands on issues, Public Health Law Watch is launching a new blog series aimed at identifying and exploring some of the public health issues and policies under consideration by candidates.

In the first part of the series, we will unpack issues like harm reduction, gun control, and more, and highlight where each candidate stands in support or opposition to law, policies, and/or programs that fall within those topic areas.

The second part of the series will dive deeper into each candidates’ proposed policies and offer critical analysis and commentary about the potential strengths and areas for improvement within those policies.

The goal of this series is to provide a deeper look at the ways in which candidates may or may not be including a public health framework in their overall healthcare reform policies, and encourage candidates to thoughtfully and purposefully develop nuanced, evidence-based, impactful policies. We also hope to inform voters as they continue to evaluate each candidate’s efforts to articulate plans to addressing healthcare and public health challenges in the U.S. Our goal is not endorse a particular candidate or political party; rather, our goal, as always, is to research, analyze, inform, and equip people with the knowledge they need to be engaged and thoughtful members of their communities and this nation.

This blog series will also link to related activities we have planned around social media, community engagement, and candidate outreach.

Please check back next week for the first post in this series:
2020 Presidential Candidates: Policies for Addressing the Opioid Overdose Crisis.

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Wendy Parmet Wendy Parmet

Targeting Health: How Anti-Immigrant Policies Threaten Our Health & Our Humanity

Since taking office, the Trump Administration has instituted a wide-ranging crackdown on immigration. A surprising number of the policies the Administration has instituted as part of that crackdown relate directly or indirectly to health.

By Patricia Illingworth and Wendy E. Parmet

On May 19th of last year, Carlos Gregorio Hernandez Vasquez died of the flu while being held in a cell by Customs and Border Protection (CBP)  in south Texas.  He was just 16, a migrant from Guatemala.  Hours before his death, when his fever spiked to 103, a nurse suggested that he be checked again in a few hours and taken to the emergency room if he got any worse.  Instead, Carlos was moved to a cell and isolated.  By morning, he was dead.

Sadly, Carlos’s substandard medical treatment was not an isolated case. Between December 2018 and May 20 2019, five migrant children died while in federal custody. All of them were from Guatemala. Their deaths were not accidental. Rather, they died as a consequence of  harsh policies that are designed to deter immigration, in part, by making life itself precarious for migrants.

Since taking office, the Trump Administration has instituted a wide-ranging crackdown on immigration. A surprising number of the policies the Administration has instituted as part of that crackdown relate directly or indirectly to health. For example, in addition to providing inadequate treatment to sick migrants, CBP has refused to provide flu shots to detainees, despite the fact that influenza, like other infectious diseases, can spread rapidly in overcrowded detention facilities. In dismissing a CDC recommendation to provide the vaccines CBP cited the complexity of administering vaccines and the fact that most migrants spend less than 72 hours in its custody, before being transferred to other agencies, or returned to Mexico, explanations that lack credibility given how easy it is to administer flu vaccines…

Click here to read the full post on the NYU Press Blog, From the Square

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Measuring Health Privacy - Part I

In this two-part post for the Promises and Perils of Emerging Health Innovations blog symposium, Ignacio Cofone engages in a discussion centered on the importance of addressing patients’ concerns when introducing new health technologies.

This piece is part of a blog symposium featuring commentary from participants in the Center for Health Policy and Law’s annual conference, Promises and Perils of Emerging Health Innovations, held on April 11-12, 2019 at Northeastern University School of Law. The symposium was originally published on the Northeastern University Law Review Online Forum.

By Ignacio N. Cofone

For e-health treatments to be operational, including electronic health records and remote patient monitoring, a significant amount of personal, and often sensitive, patient information is collected and frequently sent electronically to medical professionals and other actors.

These e-health treatments, while helpful to patients, raise privacy concerns related to a reduction in personal privacy and an increased risk of privacy breaches; privacy concerns which are not considered when evaluating their incorporation with treatments. John Carey, Power to the Patient: How Mobile Technology is Transforming Healthcare 14 (Frieda Klotz ed., 2015). Patients are indeed concerned. About half of the respondents in the survey believe that consumers’ wariness about privacy violations will be a major obstacle for the adoption of mobile technology in healthcare. Id. at 14, 16. Over half of the respondents consider privacy risks to be the biggest concern of these technologies’ application to healthcare. Id.

The absence of an objective way of taking these privacy concerns into consideration, when evaluating health policies, underplays the value patients attribute to their privacy. Moreover, unaddressed privacy concerns can lead to the halt of new and potentially advantageous treatments. See generally Ignacio N. Cofone & Adriana Z. Robertson, Privacy Harms, 69 Hastings L.J. 1039 (2018); see also Ignacio Cofone, Nothing to Hide, but Something to Lose, U. Toronto L.J. (forthcoming 2019).

I propose incorporating patients’ privacy considerations into standard health impact evaluations. Privacy concerns should be incorporated into the Quality-Adjusted Life Year framework (QALY). QALY measures the quality and quantity of life improvements per medical treatment. See Joseph S. Pliskin et al., Utility Functions for Life Years and Health Status, 28 Operations Res. 206, 213 (1980); Richard Zeckhauser & Donald Shepard, Where Now for Saving Lives?, 40 Law & Contemp. Probs. 5, 11-15 (1976).

Through such a method, I propose estimating the privacy-cost per treatment, contingent on the type of personal information involved, with similar methodologies used to evaluate QALY in health economics: Visual Analogue Scale, Standard Gamble, and Time-Trade-Off (all of which are techniques to measure individual’s characteristics, quality of life, attitude and/or preferences in a clinical context). These evaluation methods capture the patients’ subjective assessments of harm. Such costs can be used to weigh the QALY factors and then balance them against health benefits.

How Health Economics Measures What Cannot Be Quantified

Comparing treatments is no easy task. It often demands comparing technologies that have different effects on a patient’s health. For instance, one medication may lower cholesterol levels while another may provide pain relief, making them difficult to compare on a single scale.

To rank treatments on a comparable scale, health economics uses QALYs. David O. Meltzer & Peter C. Smith, Theoretical Issues Relevant to the Economic Evaluation of Health Technologiesin 2 Handbook Of Health Economics 433, 439 (Mark V. Pauly et al. eds., 2011); J. Brazier et al., A Review of the Use of Health Status Measures in Economic Evaluation, 3 Health Tech. Assessment 1, 3-4 (1999).

A QALY represents the value of living a year in perfect health, and it is used as a proxy for the quality of one’s life during that year. Paul Dolan, The Measurement of Health Related Quality of Life for Use in Re-Source Allocation Decisions in Health Carein 1B Handbook of Health Economics 1723-26 (A.J. Culyer & J.P. Newhouse eds., 2000).

The benefit of a given treatment is translated into the QALY gain that the treatment is expected to provide—both in terms of duration and quality of life. In our pain-lowering and cholesterol-lowering medication example, while the cholesterol medication may extend one’s life, the improved quality of life offered by the pain-reduction medication might make this treatment more favorable.

The question that arises is, how one can measure a person’s quality of life? This is where the Visual Analogue Scale, Standard Gamble, and Time Trade-off tools are utilized. Paul Dolan & Matthew Sutton, Mapping Visual Analogue Scale Health State Valuations onto Standard Gamble and Time Trade-off Values, 44 Soc. Sci. Med. 1519, 1519 (1997).

Each method begins with the health state that the researcher must consider. Paul Dolan et al., Valuing Health States: A Comparison of Methods, 15 J. Health Econ. 209, 210 (1996). Rather than naming actual conditions or diseases, health states are often given in terms of several “dimensions” of health and well-being, such as mobility, self-care, ability to perform everyday tasks, pain or discomfort, and mental health. Id. at 215; Dolan & Sutton, supra, at 1521. For example, a person experiencing “Health State A” may experience the following dimensions:

  • You have poor mobility.

  • You have some problems washing and dressing yourself.

  • You have some problems with performing your usual activities.

  • You experience moderate pain or discomfort.

The Visual Analogue Scale asks individuals to pinpoint visually on a scale from 0 to 100 how much they would value a given health state. David Parkin & Nancy Devlin, Is There a Case for Using Visual Analogue Scale Valuations in Cost-Utility Analysis?, 15 Health Econ. 653, 655 (2006). The average value selected by individuals is then directly translated to QALYs.

In a Standard Gamble (a method for assessing individual preference(s)), patients are asked to compare their current health state against their definition of perfect health. The QALY value is established by the lowest probability of living in perfect health that people consider being high enough to take the treatment that “cures” them from the described health state. Milton C. Weinstein et al., QALYs: The Basics, 12 Value Health S5, S9 (2009).

For example, if patient A is indifferent between living with chronic migraines and taking a treatment that will (1) cure her migraines with a probability of 95% and (2) cause death with a probability of 5%, then the QALY value of the treatment is 0.95. For the patient, the described health state is 95% as acceptable as perfect health.

The Time-Trade-Off method asks respondents to make a choice similar to that rendered under the Standard Gamble method, but by comparing years in perfect health (X) versus years experiencing a health problem (Y), against the ratio among them (X:Y) to determine the QALY value. Id. at S7. To illustrate, if patient A from the example above has no preference between living for 50 more years with migraines and living for 40 more years in perfect health, then the QALY value of the treatment is 0.8. QALY values are used to select a treatment, when there is a choice, among programs.

Placing Privacy in Health Economics

Privacy costs should be embedded within QALYs. The sharing of data with medical professionals, and the probability of patient data becoming public, can be included in the descriptions of the health states on which the Visual Analogue Scale, Standard Gamble, and Time-Trade-Off methods operate.

Imagine that a new medical intervention becomes available for an illness. This intervention improves a patient’s health. However, the intervention also involves continuous external collection of the patient’s sensitive data, such as heart rate and location. To fully assess this treatment would require consideration of the patient’s privacy concerns. A slight alteration of the traditional Visual Analogue Scale, Standard Gamble, and Time-Trade-Off methods can measure such concerns. As before, each of these methods would begin with a description of the health state under inspection In addition to the traditional “dimensions” of health, the health state could also describe the data being collected, which individuals have access to the data, and the risk of a data breach. The resulting health description could look something like this:

Modification of Health State “A” description:

  • You have poor mobility.

  • You have some problems washing and dressing yourself.

  • You have some problems with performing your usual activities.

  • You experience moderate pain or discomfort.

  • You are not anxious or depressed.

  • Data on your heart rate is being collected.

  • Data on your location is being collected.

  • Your doctor and other employees of the hospital have access to this data.

  • There is a 2% risk that the data becomes publicly available.

After presenting this altered version of health state A, its valuation would then continue as it otherwise would under the chosen method. The resulting valuation of this health state would provide an estimate of the utility of being in health state A, which includes the individual’s privacy concerns. Under this model, the QALYs would present a more complete picture of the non-monetary costs of the medical intervention.

Accounting for privacy concerns in this way could also take place in an experimental setting to evaluate current treatments. Two groups could be posed Standard Gamble or Time-Trade-Off questions, with only one of the groups facing a modified health state description such as that specified above. By comparing both groups’ valuation, there would be a resultant indication of the value patients place on losing personal information in exchange for gaining a health benefit. Large disparities between the modified health state and the non-modified health state might indicate that the current ranking of programs does not represent patients’ true preferences and well-beings. Alternatively, if the proposed method were to be followed for a few e-health treatments, its results could be tested against existing QALY evaluations of other health treatments to compare the outcomes of the standard evaluations with those of the proposed method.

Conclusion

As medical treatments have become increasingly invasive and data intensive, concerns have been raised regarding the privacy of patients. I propose the described method to quantify privacy concerns in health law, which is borrowed from health economics. See Ignacio N. Cofone, A Healthy Amount of Privacy: Quantifying Privacy Concerns in Medicine, 65 Clev. St. L. Rev. 1 (2017). This method would provide some indication of the value of personal information in a medical context and include privacy in the overall costs-benefit analysis for e-health programs. I suggest this be accomplished by incorporating privacy concerns into the cost-effectiveness framework that is already established and employed in public health policy. In Part II of this blog post, I explore the policy advantages and doctrinal consequences of this proposal.

This is Part I of a two-part blog post. Many of these ideas are developed in more detail in Ignacio N. Cofone, A Healthy Amount of Privacy: Quantifying Privacy Concerns in Medicine, 65 Cleveland State L. Rev. (2017). I thank the participants of the Northeastern University School of Law 2019 Annual Health Law Conference for their helpful comments and Malaya Powers for her excellent research assistance.

Bio: Ignacio Cofone is an assistant professor of law at McGill University’s Faculty of Law.

Handle: @IgnacioCofone

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A Delicate Balance: Proposed Regulations May Upset the Tension Between Accessibility and Privacy of Health Information

This piece is part of a blog symposium featuring commentary from participants in the Center for Health Policy and Law’s annual conference, Promises and Perils of Emerging Health Innovations, held on April 11-12, 2019 at Northeastern University School of Law. The symposium was originally published on the Northeastern University Law Review Online Forum.

This piece is part of a blog symposium featuring commentary from participants in the Center for Health Policy and Law’s annual conference, Promises and Perils of Emerging Health Innovations, held on April 11-12, 2019 at Northeastern University School of Law. The symposium was originally published on the Northeastern University Law Review Online Forum.

By Oliver Kim

Northeastern University School of Law’s “Promises and Perils” conference allowed my coauthor and me to continue the exploration of legal, policy, and ethical issues in the development and use of “disruptive technologies” in health care. See Ne. Univ. Sch. L., Promises and Perils of Emerging Health Innovations, (last visited Oct. 4, 2019); Oliver J. Kim, The Devil is in the Data, Balkinization (Nov. 3, 2018, 11:00 AM). The bedrock of the provider-patient relationship is trust, and that same level of trust must exist in the world of disruptive technology, such as digital health, if disruptive technologies will be welcomed by patients and consumers.

Consultant and health technology expert Susannah Fox argues that a “trust gap” has emerged because the narrative around digital health has negatively impacted people’s sense of trustworthiness due to “a steady drip-drip-drip of articles documenting how health apps are sharing data with third parties.” Susannah Fox, Trust Gap: Health Apps and Data Sharing (Apr. 29, 2019). Moreover, observers have raised concerns about how digital technologies affect women, people of color, and those of limited means in areas such as privacy, security, and criminal justice. See Emily Chang, What Women Know About the Internet, N.Y. Times (Apr. 10, 2019); Cat Zakrzewski, The Technology 202: Advocate Urges Congress to Protect Digital Rights of People of Color as it Crafts Privacy Bill, Wash. Post (Feb. 6, 2019); Mary Madden, The Devastating Consequences of Being Poor in the Digital Age, N.Y. Times (Apr. 25, 2019). For example, many questions about privacy arose when police were able to use a private company’s DNA ancestry tool to identify the Golden State Killer through partial matches from relatives’ genetic data. Avi Selk, The Ingenious and ‘Dystopian’ DNA Technique Police Used to Hunt the ‘Golden State Killer’ Suspect, Wash. Post (Apr. 28, 2018); Clare Wilson, Serial Killer Suspect Identified Using DNA Family Tree Website, New Scientist (Apr. 27, 2018). Some law enforcement agencies are building up their own DNA databases, and while the DNA may be taken consensually, individuals may not realize their DNA could be retained or used for other purposes. Jay Stanley, The Police Want Your DNA to Prove You’re Innocent. Do You Give it to Them?, ACLU (Sept. 16, 2016). As one physician noted after police swabbed his son, “My concern… is that it’s not just Adam’s DNA…. It’s my DNA, it’s my wife’s DNA, and our parents. Not to sound bad, but you just get nervous.” Lauren Kirchner, DNA Dragnet: In Some Cities, Police Go from Stop-and-Frisk to Stop-and-Spit, ProPublica (Sept. 12, 2016).

While improved healthcare interoperability is a priority for stakeholders, achieving it continues to be a vexing problem. Kate Monica, Top 5 Challenges to Achieving Healthcare Interoperability, EHR Intelligence (Aug. 14, 2017). After an extended comment period, the Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator (ONC) recently closed the long-awaited proposed regulations on interoperability as directed by the 21st Century Cures Act. Press Release, U.S. Dep’t of Health & Human Serv., HHS Extends Comment Period for Proposed Rules to Improve the Interoperability of Electronic Health Information (Apr. 19, 2019); Elise S. Anthony & Michael Lipinski, 21st Century Cures ACT: Interoperability, Information Blocking, and the ONC Health IT Certification Program Proposed Rule, The Office of the Nat’l Coordinator for Health Info. Tech. (last visited Oct. 8, 2019). These proposed regulations require certain payers— Medicare Advantage private plans, Medicaid and Children’s Health Insurance Program managed care organizations, Medicaid state agencies, and qualified health plans within Federally Facilitated Exchanges—to create open APIs (Application Programming Interfaces) that patients could use through a third-party app to access and compile their health data. Patient Protection, Interoperability and Patient Access for Medicare and Medicaid Programs, 84 Fed. Reg. 7610 (proposed Mar. 4, 2019) (to be codified at 40 C.F.R. pt. 156); 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program, 84 Fed. Reg. 7424 (proposed Mar. 4, 2019) (to be codified at 40 C.F.R. pt. 170 & 171).

While the use of APIs and third-party apps may make health data more accessible and help to eliminate the digital divide on how different racial and ethnic groups tend to access the Internet, there is concern about utilizing third-party apps because of their potential for harnessing consumers’ data. Eva Chang et al., Racial/Ethnic Variation in Devices Used to Access Patient Portals, 24(1) Am. J. of Managed Care e7 (2018); Rebecca Pifer, HHS Officials Defend Interoperability Rules to Senate Critics, Health Care Dive (May 7, 2019). Indeed, one of the reasons cited for the extension of the comment period was confusion over whether providers would be liable for how patients use their health data under HIPAA’s privacy law (which ironically does not contain the word “privacy” in its full title, the Health Insurance Portability and Accountability Act of 1996). Jessica K. Cohen, HHS Extends Comment Period for Interoperability Rules, Modern Healthcare (Apr. 19, 2018); Health Insurance Portability And Accountability Act of 1996, Pub. L. No. 104-191, § 110 Stat. 1936, (1996).

HIPAA protections do not necessarily apply to a third-party app simply because the app has received health information via the consumer. See Health App Developers, What Are Your Questions About HIPPA? (last visited Oct. 8, 2019). In some cases, it would be no different than if a patient handed a paper file to a stranger who promised to take care of the information. See Focal Point Insights, When Does HIPAA Apply to Health Apps?, Focal Point Blog (Oct. 3, 2018). In this instance, the consumer has voluntarily taken their patient data outside HIPAA’s world of covered entities. Instead, it would be up to the Federal Trade Commission (FTC) to take enforcement actions against those who may have violated an app’s terms and conditions with the consumer. See Federal Trade Commission, Privacy and Security Enforcement (last visited Oct. 8, 2019); G. S. Hans, Privacy Policies, Terms of Service, and FTC Enforcement: Broadening Unfairness Regulation for a New Era, 19 Mich. Telecomm. & Tech. L. Rev. 163 (2012).

As argued earlier, see Kimsupra, and as discussed in presentations, trust is a key component of ensuring that the digital health system will work, as well as building the data foundation necessary for new advances in healthcare, such as artificial intelligence. See Ne. Univ. Sch. L., supra; Ariz. St. Univ. C. L., Governance of Emerging Technologies & Science (GETS) (last visited Oct. 8, 2019). Many communities of color share concerns about the use of their health data due to historical inequities and unjust treatment by the medical system; yet, their data is needed to ensure that there is no digital divide in our healthcare databases. See J. Corey Williams, Black Americans Don’t Trust our Healthcare System – Here’s Why, The Hill (Aug. 24, 2017); Research America, New National Public Opinion Poll Shows Majority of Americans Would Participate in Clinical Trials if Recommended by Their Doctor, ResearchAmerica! Polls (June 12, 2013); Graham MacDonald & Ajjit Narayanan, We Need Better Tools to Measure Bias in Data that Drive Decisionmaking, Urban Institute (Mar. 5, 2019). The proposed regulations are unlikely to close that trust gap, particularly when consumer groups have raised concerns about certain apps, wearables, and their relationships with marketers and insurers. See Drew Harwell, Is Your Pregnancy App Sharing Your Intimate Data with Your Boss?, Wash. Post (Apr. 10, 2019); Allison V. Smith, With Fitness Trackers in the Workplace, Bosses can Monitor your Every Step – and Possibly More, Wash. Post (Feb. 16, 2019); Kaitlyn Tiffany, Period-Tracking Apps are Not for Women, Vox (updated Nov. 16, 2018); Smartphone Contraception: Policy Issues, National Women’s Health Network (last updated Oct. 2018).

Ideally, everyone would be an informed consumer, but the truth is most of us do not read or do not understand the terms and conditions that go along with downloading an app. Caroline Cakebread, You’re Not Alone, No One Reads Terms of Service Agreement, Business Insider (Nov. 15, 2017). And the current Administration has not signaled a willingness to intervene on behalf of consumers. For instance, the new head of the Consumer Financial Protection Bureau said the agency will help consumers “to help themselves [to] protect their own interests” rather than on focus on enforcement. David Lazarus, ColumnL CFPD head, Charged with Protecting Consumers, Says People Need ‘to Help Themselves’, LA Times (Apr. 19, 2019). Similarly, ONC director Don Rucker said it is up to individual patients to decide what types of third-party apps to use. See Cohensupra.  Let the downloader beware!

While CMS and ONC do not have regulatory authority over third party apps, they could allow or require APIs to restrict third-party apps’ access based on whether they agree to limit the use of patients’ health data. As one consumer group has argued, that would give patients some real measure of choice in their notice and consent. And to build trust—particularly for women and people of color—in this digital revolution in healthcare, the government owes patients and consumers some sense of safety and security. See Michell Richardson, Notice and Choice Are No Longer a Choice, CDT Blog (Mar. 1, 2019).

Bio: Oliver Kim is an adjunct law professor at University of Pittsburgh School of Law and a principal with Mousetrap Consulting in Washington, D.C.

Handle: @mousetrapdc

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Event: World AIDS Day at Northeastern University

Join us for a day of solidarity in support of World AIDS Day 2019. Brought to you by Northeastern University School of Law's Center for Health Policy and Law, Center for Law, Innovation and Creativity, Center for Public Interest Advocacy and Collaboration, and Northeastern University's Partners in Health Engage. 

Join us for a day of solidarity in support of World AIDS Day 2019. 

Brought to you by Northeastern University School of Law's Center for Health Policy and LawCenter for Law, Innovation and CreativityCenter for Public Interest Advocacy and Collaboration, and Northeastern University's Partners in Health Engage

All are welcome to attend!

December 2, 2019

Schedule:

Discussion Panel
12:00 - 1:30 PM | 220 Dockser Hall 

Moderator:
Dr Anatole Manzi
Director of Clinical Practice and Quality Improvement, Partners in Health (PIH)

Panelists:
Aziza Ahmed
Professor of Law, Northeastern University School of Law
Brook K. Baker
Professor of Law, Northeastern University School of Law
Dr. Cassandra Pierre
Assistant Professor of Medicine, Boston University School of Medicine

Tabling Event: Know Your Status, Know Your Risk 
12:00 - 3:00 PM | Curry Student Center 

Members of Partners in Health Engage (PIHE) will host a tabling event focused on increasing awareness and education about ways for students to actively engage in the fight against HIV/AIDS. Materials and resources related to access to prevention, testing, treatment, medications, reproductive health education, and counseling will be available for those interested. 

Film Screening: Fire in the Blood
5:00 - 7:30 PM | 250 Dockser Hall 

Film screening of Dylan Mohan Gray's documentary "Fire in the Blood" with post-film discussion featuring James Love, Director of Knowledge Ecology International and Brook K. Baker, Professor of Law at Northeastern University School of Law. 

Questions? Email Gianina Chua at g.chua@northeastern.edu

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