The health care system of the future is taking shape right now, and the foundation of that new system is health care data that is private, trusted and secure. Today, we are pleased to release the final Data Security Policy Principles and Framework (Security Framework) for President Obama’s Precision Medicine Initiative (PMI). The types, breadth, and sensitivity of the personal health, genetic, and environmental information that may be part of a precision medicine-type activity warrants careful attention and protection. Therefore, the Security Framework (modeled on the Administration’s Cybersecurity Framework) establishes security expectations for organizations who participate in PMI and provides a risk management approach to achieving those principles. To ensure that we are leading by example, Federal PMI agencies have committed to integrate the framework throughout all PMI activities.

On January 30, 2015, President Obama launched PMI to enable a new era of medicine – one where doctors and clinicians are empowered to tailor their treatments to their patients’ needs, and patients can get individualized care. With new advances in medical research, our health care system can deliver the right treatment to the right patient at the right time, taking into account an individual’s health history, genetics, environment, and lifestyle.

Since the launch of the initiative, researchers, technologists, and potential participants have shared their excitement for this vision. At the PMI Summit in February, the Administration announced over 40 major commitments from the private sector that will advance precision medicine, including commitments from seven major electronic health record (EHR) vendors to implement technology that allows patients to easily send their EHR data to the PMI cohort.

Our greatest asset in PMI is the data that participants contribute, and we want to make sure participants know that their data is protected. The Security Framework we are releasing today builds on the existing PMI Privacy and Trust Principles and ensures we put the security of participants’ information first.

We recognize that there is no “one-size-fits-all” approach to managing data security.  This is why the Security Framework, which builds on the National Institute of Standards and Technology (NIST) Cybersecurity Framework, is designed to be adaptable and responsive to the needs of multiple participating PMI groups, providing a broad framework for protecting participants’ data. Additionally, the Security Framework emphasizes transparency with participants, the public, and with other precision medicine organizations so that groups can learn from each other’s experiences and challenges. Organizations can use the framework to develop detailed implementation guidelines that address their specific data security needs.  With this flexibility, we can make use of rapid evolutions in medicine, research and technology while still protecting participants’ information.

Finally, we are committed to helping organizations develop these tailored requirements. The Office of the National Coordinator for Health Information Technology and the Office for Civil Rights, in partnership with NIST, other Federal partners, and a broad set of stakeholders, will release a precision medicine-specific guide to the NIST Cybersecurity Framework by December 2016.

Today, our health care system is standing on the verge of unprecedented breakthroughs in the way we care for patients and treat disease. Thanks to President Obama’s Precision Medicine Initiative, we have a greater opportunity to make those breakthroughs a reality. And by protecting the health care data that powers those breakthroughs, we can make sure that every American is healthier and their health care data is secure.

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We lose too many of our fellow Americans to drug overdoses. Especially alarming is the high rate of prescription drug overdose and the rising rate of overdoses due to heroin use. In 2012 alone, 259 million opioid prescriptions were written -- enough for every American adult to have a bottle.

Rural America, including my home state of West Virginia, knows this issue all too well. Opioid injuries and overdoses are very real and affect many families. The situation is urgent – but there is reason for optimism: There are targeted actions we can take to save lives and turn these trends around. But we need all stakeholders at the table.

Therefore, I am asking federal, state and local government officials, doctors, treatment providers, drug companies, individuals and family members to work together to address this nationwide crisis.

At the U.S. Department of Health and Human Services, we’re working to develop the most effective solutions to reverse this trend. We’ve used the best evidence to determine where to focus our attention and turn the tide against opioid drug-related overdose and dependence. Today, we announced a targeted initiative aimed at reducing prescription opioid and heroin related overdose, death, and dependence. Our efforts focus on three promising areas: informing opioid prescribing practices, increasing the use of naloxone - a drug that reverses symptoms of a drug overdose, and using medication-assisted treatment to slowly move people out of opioid addiction. Additionally, the President’s FY 2016 budget includes critical investments to intensify efforts to reduce opioid misuse and abuse, including $133 million in new funding to address this critical issue.

We share common interests and therefore have an opportunity to work together in common cause. Whether we happen to work at state, local, or federal level – and regardless of whether we are in the private or public sector – this is an issue that knows no geographic or ideological boundaries. We all have a stake in saving more lives and we all have a role to play in building safer, stronger, and healthier communities. 

For more info see here and here.

For more information about prescription medication abuse and dependence:

 www.samhsa.gov/prescription-drug-misuse-abuse

Learn the signs of prescription drug use disorders:

 www.drugabuse.gov/publications/research-reports/prescription-drugs/opioids

If you or someone you know is struggling with a prescription drug use disorder, help is available 24 hours a day, 7 days a week:

 National Treatment Referral Helpline 1-800-662-HELP (4357) or 1-800-487-4889 (TDD)

 National Substance Abuse Treatment Facility Locator: www.findtreatment.samhsa.gov

With just two days to go until the start of Open Enrollment, I want to share with you what we've been doing at the Department of Health and Human Services to expand access to quality, affordable coverage to more people and to lay the groundwork for a successful Open Enrollment.

First, we're committed to improving the consumer experience.

We've listened to feedback and have put that learning into practice. Most consumers who come back to HealthCare.gov to renew their coverage will find about 90% of their application is pre-populated, based on answers from last year. Consumers who are renewing coverage, as well as consumers shopping for coverage for the first time, will have 25% more options to choose from on average. That means consumers can shop and find a more affordable plan that better meets their needs. And we've added 1,000 representatives to our 24-hour call center to answer questions and help consumers get and stay covered.

We also understand that it's our job to protect consumers' security and we take that responsibility seriously.

We've tested and retested our systems, putting ourselves through some of the industry's most stringent protocols to ensure we're taking the steps necessary to safeguard consumers' personal information. We've enhanced our cybersecurity team with experts from the public and private sector to raise the bar on security. And we'll be focused every day on what more we can do to improve our ability to respond to cybersecurity events quickly and effectively if needed.

If you signed up for Marketplace coverage during last Open Enrollment:

We encourage you to come back to HealthCare.gov, reach out to the call center, or meet with an in-person assister to make sure you choose the plan that's right for you and get the best financial help available.

Starting November 15, if you're renewing your coverage, you should log into your account.

By doing so, you can make sure your household income and other information is up-to-date, compare your current plan with other plans available in your area, select the plan that best meets your needs and budget, and choose a plan by December 15 for coverage starting January 1.

If you're shopping for coverage for the first time, Open Enrollment runs from November 15 to February 15. Your coverage can start as soon as January 1 if you sign up by December 15.

All consumers should visit HealthCare.gov or reach out to our 24/7 call center with any questions: 1-800-318-2596 (TTY 1-855-889-4325). Information about in-person assistance is available at localhelp.healthcare.gov.

Join the millions of Americans who now have access to quality, affordable coverage: Sign up between November 15 and February 15.