WHITE HOUSE FACT SHEET ON NEW PATIENT-FOCUSED COMMITMENTS

FROM:  THE WHITE HOUSE
FACT SHEET: New Patient-Focused Commitments to Advance the President’s Precision Medicine Initiative

“Doctors have always recognized that every patient is unique, and doctors have always tried to tailor their treatments as best they can to individuals. You can match a blood transfusion to a blood type — that was an important discovery. What if matching a cancer cure to our genetic code was just as easy, just as standard? What if figuring out the right dose of medicine was as simple as taking our temperature?” -- President Barack Obama, January 30, 2015

In January 2015, President Obama launched the Precision Medicine Initiative (PMI), a bold new research effort to revolutionize how we improve health and treat disease, empowering health care providers to tailor treatment and prevention strategies to individuals’ unique characteristics. In launching PMI, the President acknowledged that success in this effort will require all hands on deck – including the active participation of care providers, health professionals, researchers, innovators, patients, and research participants.

Today, marking six months of progress to advance PMI, the White House is hosting a Champions of Change event honoring extraordinary individuals from across the country who are making a difference in the lives of patients and driving precision medicine forward. In addition to celebrating these Champions, Federal agencies and private-sector groups are stepping up to the President’s call to action to advance the PMI by making important commitments to:

Make health data more portable;
Ensure patients can easily access and share their own health information, including contributing it for research;
Rigorously protect patient privacy, security and choice; and
Support new research platforms connecting researcher and participants as partners.
Administration commitments launching today include:

Guiding Principles for Protecting Privacy and Building Trust: Today, the White House is unveiling draft PMI guiding principles that seek to build privacy into the design of the PMI research cohort, which will include one million or more Americans who agree to share data about their health.   An interagency working group convened by the White House developed these principles out of a series of expert roundtables, review of the bioethics literature, analysis of existing privacy and trust frameworks, and working group discussions. The principles articulate a set of core values and responsible strategies for building public trust and maximizing the benefits of a large national research cohort, while minimizing the risks inherent in large-scale data collection, analysis and sharing.  The White House is seeking public feedback on the Privacy and Trust Principles online through August 7, 2015.

New Tools for Patients: In collaboration with federal partners, the Department of Health and Human Services Office of the National Coordinator for Health IT (ONC) and Office for Civil Rights (OCR) will work to address barriers that prevent patients from accessing their health data. OCR will develop additional guidance materials to educate the public and health care providers about a patient’s right to access his or her health information under the Health Insurance Portability and Accountability Act (HIPAA).  In collaboration with the White House Social and Behavioral Sciences Team, ONC will publish sample communications tools to encourage patients to access their digital health information and workflow diagrams for providers. These resources draw on extensive user research and proven practices to encourage patients to view, download, and transmit their health information. ONC is also developing an open-source prototype that will allow individuals to combine their medical records with patient-generated data and connect these data with the apps of their choice.

Research Awards to Unlock Data Insights: Today the Department of Veteran Affairs (VA) is announcing awards to support four research projects on key questions relevant to precision medicine using the rich data from the Million Veterans Program (MVP), the largest US repository of genetic, clinical, lifestyle and military exposure data. The projects, which focus on the genetic contributions of heart disease, kidney disease, and substance abuse, are designed to assess the utility and accessibility of the data captured in MVP, in addition to answering important scientific questions. These studies will also help inform plans for PMI’s national research cohort, including the types of data that should be included and the design of the data platform. To date, over 390,000 Veterans have enrolled in MVP, and have provided a blood sample, answered a health questionnaire, and authorized access to their electronic health records (EHRs). Understanding how these data, when combined, can help uncover new insights into factors that affect disease onset and progression will be an important test for all precision medicine focused cohorts.

Private-sector commitments launching today include:

Duke Center for Applied Genomics and Precision Medicine: Duke has developed a platform called MeTree that helps individuals have challenging but necessary conversations with loved ones and care providers about family health histories, so that physicians can tailor care to patients’ unique risk profiles. Duke is announcing that, leveraging emerging standards, MeTree will now connect with the information in patients’ electronic health records, allowing patients and providers to seamlessly access information in EHRs through application programming interfaces (APIs).  This effort aims to enrich communication between patients and their clinicians and to help them make the best possible care decisions as a team.

Flip the Clinic: Flip the Clinic, a project of the Robert Wood Johnson Foundation, is announcing a collaboration with more than 160,000 clinicians and staff practicing at sites across the United States, who have pledged to inform patients about their right to get digital copies of their medical records. Flip the Clinic will work hand-in-hand with clinicians at these sites to redesign how clinicians respond to patients’ requests for their own records, with the goal of making health-information access, sharing, downloading, and use a more seamless experience for both patients and clinicians. Flip the Clinic is further committing to educate patients about the President’s Precision Medicine Initiative and how to get involved. Collaborators in this effort include a wide range of delivery systems, clinics, organizations, and technology partners.

Genetic Alliance: Along with collaborators, Genetic Alliance is launching new capabilities for Platform for Engaging Everyone Responsibly (PEER), a data registry that empowers participants to share their data with medical researchers, advocacy groups, and others. With assistance from Cerner and NATE, going forward, PEER will accept coded, clinical data from participants’ electronic health records (EHRs). Participants will be able to send this information to PEER directly from their provider-supplied portals, leveraging national standards, or ask that their providers send it. PEER is a free-to-the-participant user service that is provided through condition-specific advocacy and support groups. Each participant is provided with tools to dynamically control how much of their information they wish to share, and with whom. Currently there are about 20 provider-supplied portals that work with PEER. Through a grant from the Robert Wood Johnson Foundation, this number will more than double by the end of 2015. Additional collaborators on this effort include: Private Access, Cerner Corporation, National Association of Trusted Identities (NATE).

GetMyHealthData: The GetMyHealthData campaign is pledging to help thousands of consumers over the next 12 months access and download their own clinical health data, so they can use it to understand and improve their health, their care, and the system as a whole -- including donating their data for research. The campaign is a collaboration of consumer organizations, health care experts, former policy makers and technology organizations.  GetMyHealthData will guide consumers through the often complex process by providing a tool to automate the request for their data and to troubleshoot any problems that occur. The initiative will also offer basic guidance on apps that can safely and securely store patient data, including those that enable data donation for research while protecting privacy. Finally, the campaign will provide resources for clinicians and consumers that explain consumers’ rights and best practices to get copies of their structured electronic clinical data. Collaborators include: National Partnership for Women & Families, Amida, Code for America, Genetic Alliance, Health Data Consortium and NATE.

Sage Bionetworks: Recognizing the importance of health-data liberation, and the role of data in driving research studies, Sage Bionetworks is announcing that it will support clinical studies that import electronic health-record information to its open source research platform and that it will release open-source informed-consent prototypes to support these studies. Sage’s goal is to catalyze new clinical studies that are native to mobile phones, vastly expanding the ability of citizens to voluntarily participate and engage as partners in research. Sage Bionetworks leverages the power of open networks of contributors to solve complex scientific problems, including the Cancer Genome Atlas and NIH’s Alzheimer’s Accelerating Medicine Partnership.

FTC BARS COMPANY FROM MAKING FALSE CLAIMS ABOUT APP THAT CAN DIAGNOSE MELONOMA RISK

FROM:  U.S. FEDERAL TRADE COMMISSION
FTC Approves Final Order Barring Misleading Claims about App’s Ability to Diagnose or Assess the Risk of Melanoma

Following a public comment period, the Federal Trade Commission has approved a final consent order barring Health Discovery Corporation from making deceptive or unsupported claims that its app, MelApp, could help diagnose or assess consumers’ melanoma risk.

According to the FTC’s February 2015 complaint, MelApp instructed users to photograph a mole with a smartphone camera and input other information. It would then supposedly calculate the mole’s melanoma risk as low, medium, or high. The FTC charged that Health Discovery Corporation deceptively claimed the app accurately analyzed melanoma risk and could assess such risk in early stages, and that its accuracy was scientifically proven.

The final order settling the action bars the company from claiming that any device detects or diagnoses melanoma or its risk factors, or increases users’ chances of early detection, unless the representation is not misleading and is supported by competent and reliable scientific evidence. It also prohibits Health Discovery Corporation from making any other deceptive claims about a device’s health benefits or efficacy, or about the scientific support for any product or service, and requires the company to pay $17,963.

The Commission vote approving the final consent order and was 4-1, with Commissioner Maureen Ohlhausen voting no

CDC ANNOUNCES EBOLA VACCINE TRIAL HAS BEGUN IN SIERRA LEONE

FROM:  CENTERS FOR DISEASE CONTROL AND PREVENTION
Ebola vaccine trial begins in Sierra Leone
6,000 health and other front-line workers will receive vaccine in five districts of the country

The Centers for Disease Control and Prevention (CDC), in partnership with the Sierra Leone College of Medicine and Allied Health Sciences (COMAHS) and the Sierra Leone Ministry of Health and Sanitation (MoHS), is now enrolling and vaccinating volunteers for the Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE). This study will assess the safety and efficacy of the rVSV-ZEBOV candidate Ebola vaccine among health and other frontline workers.

“A safe and effective vaccine would be a very important tool to stop Ebola in the future, and the frontline workers who are volunteering to participate are making a decision that could benefit health care professionals and communities wherever Ebola is a risk,” said CDC Director Tom Frieden, M.D., M.P.H.  “We hope this vaccine will be proven effective but in the meantime we must continue doing everything necessary to stop this epidemic —find every case, isolate and treat, safely and respectfully bury the dead, and find every single contact.”

STRIVE will enroll about 6,000 health and other frontline workers. It will be conducted in Western Area Urban district, which includes Freetown, Western Area Rural district, and certain chiefdoms in Bombali, Port Loko, and Tonkolili districts. These study locations were selected because they have been heavily affected by the Ebola outbreak in the past few months.

“We are happy to be partnering with MoHS and CDC on this important study, which may help to prevent future cases of Ebola,” said Mohamed Samai, M.B., Ch.B., Ph.D., acting Provost of COMAHS and the study’s principal investigator. “It brings me hope and pride that my country can take from this devastating epidemic something that may benefit people around the world.”

When participants enroll in the study, they will be assigned randomly to one of two timeframes for vaccination – either immediately or about six months later. All study participants will receive the vaccine and be followed closely for six months. The study will evaluate if and how well the vaccine worked by comparing rates of Ebola virus disease in those who are vaccinated to those who have not yet received the vaccine.

DEFENSE SECRETARY CARTER STOPPED IN KANDAHAR TO THANK TROOPS

FROM:  U.S. DEFENSE DEPARTMENT

Right:  U.S. Defense Secretary Ash Carter talks with troops on Kandahar Airfield, Afghanistan, Feb. 22, 2015. Carter answered a range of questions and thanked troops for their service. DoD photo by Glenn Fawcett.  

By Cheryl Pellerin
DoD News, Defense Media Activity

WASHINGTON, Feb. 22, 2015 – As part of his first official trip to Afghanistan as defense secretary, Ash Carter made a stop in Kandahar today to thank U.S. troops there for their dedication to the mission and the progress they and their NATO and Afghan allies have achieved.

His visit was to the Train Advise and Assist Command South, or TAAC South, formerly Regional Command South. The command’s area of responsibility includes the provinces of Kandahar, Uruzgan, Zabul and Daykundi.

The U.S. 1st Cavalry Division is what is called the TAAC South framework element, and contributing countries include Romania, Slovakia, the United Kingdom, Belgium, Australia, Jordan and Georgia.

At TAAC South’s Kandahar Airfield headquarters, Carter told the troops that they are his priority.

Thanking the Troops

“You're what I wake up to every morning” he said. “I never forget for one minute that you're here and what you're doing, the sacrifice that being here entails and the risk that it entails for you.”

He thanked the troops personally and on behalf of the Defense Department and the nation.

While in Afghanistan, the secretary will assess progress being made in the country so he can determine future actions and make recommendations to President Barack Obama, he told service members.

The train, advise and assist mission is becoming the heart of the effort in Afghanistan that will make permanent the success that U.S. and coalition troops have sacrificed so much for, Carter said.

An Important Country in the World

“We'll never be gone from Afghanistan because Afghanistan is an important country in the world,” he added, “but when our presence here is reduced to something much smaller than today, we want to make sure that the Afghans themselves are able to preserve the environment our forces have created over the last few years, one of relative security and stability.”

Carter told the men and women in uniform that he’d met with Afghan President Ashraf Ghani and Chief Executive Dr. Abdulla Abdullah in Kabul.

“There's one thing President Ghani said that I want to share with you. He said, ‘Would you please tell your people that I appreciate the sacrifice they have made for my country.’”

Carter said, “Just think about that -- remember that.”

Questions From the Troops

Before giving each service member a coin and having his picture taken with them, Carter took questions from his audience that ranged from cybersecurity to military retirement to downsizing the force. But first he commented on the coins.
“Let me tell you a little bit about the coin. … I'm so new they haven't made coins with my name on them yet, so I'm sorry about that. It's a more generic secretary of defense coin. It may not be as valuable on eBay as an Aston B. Carter coin,” he said to laughter from the audience, “but you can trade up later.”
His first question was about the cyber dimension of building a force of the future.
“Cyber has to be part of building the force of the future -- is in fact part of the force of right now,” the defense secretary said.

Leveraging Technology

One of the reasons the United States has the finest fighting force the world has ever seen is because of the way the nation leverages technology, Carter said, especially information technology.

The field is exploding and it's everywhere in the world, he added, “and that means if we don't change and we don't keep up, we can't keep our position as the best in the world.”

The United States has a substantial lead in cyberspace now, Carter said, “and there’s no reason why we can't keep it.”

“The reason we'll stay the greatest is that we'll keep striving to be at the forefront,” the secretary added. “And in today's world the only way to be excellent is to be open to ideas from the outside. You can't think of everything yourself and you can't do everything yourself.”

Military Retirement System

To a question about the military retirement system, Carter said he’s open to reconsidering the system.

The Military Compensation and Retirement Modernization Commission studied the current system and sent its report to Carter, who said he’s studying it.
“Ultimately under the law I'm required to then tell President Obama what I think about it and I haven't had a chance to do all that yet, and absorb it,” he said.
But Carter added that his starting point is that such a system attracts those who will keep the all-volunteer force healthy in the future and that continues to offer a retirement structure that is attractive and gives recruits appropriate incentives along the way to stay in the military or retire at a time that is best for them and best for the force.

Keeping the All-volunteer Force Healthy

“That’s the criterion that I will principally apply in considering these things,” the secretary added. “It's not about money [or] anything else. It's fundamentally mostly about the health of the force in the future and that's the lens through which I will look at it.”

The military retirement system has financial implications for each individual service member and for the country as a whole, Carter said, but the priority is to make sure the services have the right people.

“Any change we make [should] be one that those already in service don't have to make if they don't want to,” the secretary said, adding that this in line with what the commission recommended.

“I don't want to breach our understanding with you at the time you joined, that's not fair, he told service members.

The services can make alternatives available to those who may join the military in the future, and available to those who are in now, Carter said, “but if we made a deal with you when you first got in, I think we ought to keep that deal.”
Defending the Nation

To a question about downsizing the military at a time when multiple national security challenges face the nation, Carter said he’s adamantly opposed to the budget cuts known as sequestration.

The sequestration process is unwise and unsafe for national security going forward,” he told troops.

“We’ve got to spend enough money on defense to protect our country and protect our interests,” the secretary said. “We just can't have a mindless mechanism that decides what the defense budget is.” The nation, he added, must decide what it needs to protect itself, its interests and its allies, and consider those elements to build a budget.

It’s also imperative, he said, to put every defense dollar to good use.

“My reaction every time somebody says … how are you spending your money? Fair enough. It’s fair enough to be challenged and make sure we're using all that money” in the best possible ways, Carter said.

NSF: "HELPING HEALTHCARE TECHNOLOGIES COMMUNICATE

FROM:  NATIONAL SCIENCE FOUNDATION 

Helping healthcare technologies communicate

Doctor develops open-source software to link healthcare systems at home and in hospitals

Julian Goldman, a physician at Massachusetts General Hospital, knows better than most the frustrations that doctors face when they're confronted with computer systems and devices that just won't communicate with each other.

The research team at his lab has been a pioneer in developing open-source software and standards designed to integrate the various technologies used in homes and hospitals. Goldman's lab created a computing platform called Open ICE (Integrated Clinical Environment) to begin to address these problems.

The effort, in turn, led to the development of a community of like-minded researchers and manufacturers that would like to break barriers in healthcare through better information exchange, better communication among and between medical devices and electronic health records, and ultimately through smart apps designed to improve patient safety and decrease the cost of health care.

"Our involvement with Smart America has been an exciting, six-month, wild ride," said Goldman, who co-chaired the Closed Loop Healthcare team with Marge Skubic, director of the Center for Eldercare and Rehabilitation Technology at the University of Missouri.

"We've all learned a lot from each other," he said. "Our contact, and our work together, has influenced our perception of our work, including how to make our own work more accessible to collaborators. That is extremely valuable and typically very hard to do."

The Smart America Expo brought together leaders from academia, industry and government to demonstrate the ways that smarter cyber-physical systems--sometimes called the Internet of Things--can lead to improvements in healthcare, transportation, energy and emergency response, and other critical areas.

-- Aaron Dubrow, NSF
Investigators
Tracy Rausch
Julian Goldman
Related Institutions/Organizations
Massachusetts General Hospital

OTEZLA APPROVED BY FDA TO TREAT ADULT ACTIVE PSORIATIC ARTHRITIS

FDA NEWS RELEASE

For Immediate Release: March 21, 2014
Media Inquiries: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov 
Consumer Inquiries: 888-INFO-FDA

FDA approves Otezla to treat psoriatic arthritis

The U.S. Food and Drug Administration today approved Otezla (apremilast) to treat adults with active psoriatic arthritis (PsA).

PsA is a form of arthritis that affects some people with psoriasis. Most people develop psoriasis first and are later diagnosed with PsA. Joint pain, stiffness and swelling are the main signs and symptoms of PsA. Currently approved treatments for PsA include corticosteroids, tumor necrosis factor (TNF) blockers, and an interleukin-12/interleukin-23 inhibitor.

“Relief of pain and inflammation and improving physical function are important treatment goals for patients with active psoriatic arthritis,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “Otezla provides a new treatment option for patients suffering from this disease.”

The safety and effectiveness of Otezla, an inhibitor of phosphodieasterase-4 (PDE-4), were evaluated in three clinical trials involving 1,493 patients with active PsA. Patients treated with Otezla showed improvement in signs and symptoms of PsA, including tender and swollen joints and physical function, compared to placebo.

Patients treated with Otezla should have their weight monitored regularly by a healthcare professional. If unexplained or clinically significant weight loss occurs, the weight loss should be evaluated and discontinuation of treatment should be considered. Treatment with Otezla was also associated with an increase in reports of depression compared to placebo.

The FDA is requiring a pregnancy exposure registry as a post-marketing requirement to assess the risks to pregnant women related to Otezla exposure.
 
In clinical trials, the most common side effects observed in patients treated with Otezla were diarrhea, nausea, and headache.  

MEDICAL TESTING COMPANY WILL PAY $3.57 MILLION TO RESOLVE FALSE CLAIMS ACT ALLEGATIONS

FROM:  U.S. JUSTICE DEPARTMENT 
Tuesday, August 27, 2013

MRI Diagnostic Testing Company, Imagimed LLC, and Its Former Owners and Chief Radiologist to Pay $3.57 Million to Resolve False Claims Act Allegations
New York-based Imagimed LLC, the company’s former owners, William B. Wolf III and Dr. Timothy J. Greenan, and the company’s former chief radiologist, Dr. Steven Winter, will pay $3.57 million to resolve allegations that they submitted to federal healthcare programs false claims for magnetic resonance imaging (MRI) services, the Justice Department announced today.  Imagimed owns and operates fifteen MRI facilities, located primarily in New York state, under the name “Open MRI.”

 Allegedly, from July 1, 2001, through April 23, 2008, Imagimed, Greenan, Wolf and Winter submitted claims to Medicare, Medicaid and TRICARE for MRI scans performed with a contrast dye without the direct supervision of a qualified physician.  Since a potential adverse side effect of contrast dye is anaphylactic shock, federal regulations require that a physician supervise the administration of contrast dye when it is used for an MRI.  Also, allegedly, from July 1, 2005, to April 23, 2008, Imagimed, Greenan, Wolf and Winter submitted claims for services referred to Imagimed by physicians with whom Imagimed had improper financial relationships.  In exchange for these referrals, Imagimed entered into sham on-call arrangements, provided pre-authorization services without charge and provided various gifts to certain referring physicians, in violation of the Stark Law and the Anti-Kickback Statute.

 “The Department of Justice is committed to guarding against abuse of federal healthcare programs,” said Stuart F. Delery, Assistant Attorney General for the Civil Division.  “We will help protect patients’ health by ensuring doctors who submit claims to federal healthcare programs follow proper safety precautions at all times.”

U.S. Attorney for the Northern District of New York, Richard S. Hartunian said: “This case is an example of our commitment to using all of the remedies available, including civil actions under the False Claims Act, to ensure patient safety and combat health care fraud.  Stripping away the profit motive for circumventing physician supervision requirements has both a remedial and a deterrent effect.  The settlement announced today advances our critical interest in both the integrity of our health care system and the safe delivery of medical services.”

The allegations resolved by the settlement were brought in a lawsuit filed under the False Claims Act’s whistleblower provisions, which permit private parties to sue for false claims on behalf of the government and to share in any recovery.  The whistleblower in this case, Dr. Patrick Lynch, was a local radiologist and will receive $565,500.

This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by Attorney General Eric Holder and Health and Human Services Secretary Kathleen Sebelius.  The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation.  One of the most powerful tools in this effort is the False Claims Act.  Since January 2009, the Justice Department has recovered a total of more than $14.8 billion through False Claims Act cases, with more than $10.8 billion of that amount recovered in cases involving fraud against federal health care programs.

The investigation and settlement were the result of a coordinated effort among the U.S. Attorney’s Office for the Northern District of New York; the Justice Department’s Civil Division, Commercial Litigation Branch and the Department of Health and Human Services’ Office of Inspector General.

The case is United States of America ex rel. Lynch v. Imagimed LLC, et al. (N.D. N.Y.).  The claims released by the settlement are allegations only, and there has been no determination of liability.

PRESIDENTS OF BRAZIL AND U.S. WANT TO STRENGTHEN HEALTH SYSTEMS WORLDWIDE

FROM:  U.S. STATE DEPARTMENT
The United States and Brazil: Health Cooperation
Fact Sheet
Bureau of Western Hemisphere Affairs
April 9, 2012
President Obama and President Rousseff are united in their desire to strengthen public health systems and to advance science and technology research, both in their own countries and around the world. For several decades the United States and Brazil have participated in a bilateral dialogue that provides a formal venue for discussing our mutual interests in medical research, disease surveillance, and improving public health. President Obama and President Rousseff have further advanced our bilateral health cooperation through the U.S.-Brazil Working Group on Public Health, under the U.S.-Brazil Joint Commission on Science and Technology.
The U.S. and Brazilian governments have a strong and fruitful relationship on health cooperation including key collaborations such as:

Field Epidemiology Training Program (EPI-SUS): EPI-SUS trains Brazilian field epidemiologists to improve disease detection and response capacity and the exchange of information globally. In addition, EPI-SUS epidemiologists participate with U.S. Centers for Disease Control and Prevention (CDC) in Stop Transmission of Polio (STOP) activities in Angola.

Global HIV/AIDS: CDC has had an in-country office in Brazil since 2003 and is co-located within the Brazilian Ministry of Health (MOH). Through collaboration with the MOH and other in-country partners, CDC activities focus on HIV/AIDS program monitoring and evaluation within the national program.

Chronic Diseases: The United States and Brazil are working together to strengthen chronic disease surveillance and evaluation. The collaboration has resulted in the establishment of a risk factor surveillance system and expansion of national physical activity programs;

Immunizations: For the past four years, the United States and Brazil, together with the Pan American Health Organization, have supported Rubella Elimination in the Americas and other immunization-related objectives.

Influenza: CDC supports increased capacity for influenza surveillance, improved laboratory sampling and testing, and enhanced rapid response capability and training through a cooperative agreement with the Brazilian MOH. In collaboration with CDC, Brazil developed the fourth version of their pandemic influenza plan in 2010, which is based on lessons learned from the 2009 H1N1 pandemic.

Research: As of 2010, Brazilian research institutions receive more National Institutes of Health (NIH)-supported international research funds than any other country in Latin America – one indicator of the high quality of their research. CDC and NIH are also partnering with Brazil in the “Science without Borders” initiative.

Cancer: Brazil is one of five member countries (also Argentina, Chile, Mexico, and Uruguay) of the U.S.-Latin America Cancer Research Network, an effort to involve regional academic laboratories, research institutes and centers, and hospital systems are developing the infrastructure to conduct and sustain high-quality cancer research throughout Latin America.

Advancement of Women’s Health: Under our joint US-Brazil Memorandum of Understanding on the Advancement of Women, we are also focusing on women’s health. Examples include a new partnership with the What to Expect Foundation to improve maternal health and literacy. The Institute for Training and Development and Smith College will partner with a Brazilian network of 53 non-government organizations (NGOs) in 16 Brazilian states, to send 20 women for six-week internships at U.S. women’s health NGOs. Our two governments are also in the early stages of considering bilateral engagement opportunities to promote women’s health in prisons.

Racial and Ethnic Disparities in Health Access and Care: Another high priority activity is the exchange of information and experts in furtherance of the Joint Action Plan to Eliminate Racial and Ethnic Disparities, which shares best practices between CDC, HHS, and the Brazilian MOH and civil society experts on racial disparities in access to health, data collection and hereditary diseases and blood disorders.

Regulatory Public Health Activity: Both the U.S. Food and Drug Administration (FDA) and ANVISA (the FDA counterpart agency within the Brazil Ministry of Health) have enjoyed a very productive and long relationship with informational exchange on processed food, medications and medical devices, and firm inspections being done by ANVISA in the U.S. and by FDA in Brazil. This relationship was further strengthened with the signing of a confidentiality commitment document by both Agencies. At this point, FDA and ANVISA are involved in pre-decisional as well as post-market assessment of regulated products and capacity-building events. With respect to the Brazil Ministry of Agriculture (MAPA which covers raw produce, fish and seafood), FDA has a close relationship with joint activity in the regulated food categories of interest and there are FDA firm inspections being conducted in Brazil.