certification,Clearwater Compliance,Compliance assessments,electronic protected health information,ePHI,HIPAA,Information Risk Management,IRM,National Institute of Standards and Technology,NIST,OCR,Office for Civil Rights,Phase 2 Audit Protocol

OCR guidance should shape your risk management program


Bob Chaput, Chief Executive Officer and Founder, Clearwater Compliance

Controls-based “checklists” and dubious certifications will not adequately protect a healthcare organization’s sensitive digital assets. What will work is a formal Information Risk Management (IRM) program designed to grow more effective and mature over time. 

Two documents from the Office for Civil Rights (OCR) reveal what the HIPAA regulatory arm of the federal government believes are appropriate for determining an organization’s level of compliance and information security as required by HIPAA: the Phase 2 Audit Protocol that covers all three HIPAA regulations and OCR’s Final Guidance on Risk Analysis, which is specific to the HIPAA Security Rule and information risk management. 

You should consider this OCR guidance when looking for tools to determine your current level of compliance and information security. These directives can also serve as a prioritization plan for remediating weaknesses and a project management tool for tracking remediation progress. The ability to document improvement in IRM compliance over time provides the evidence regularly requested by OCR – and the lack thereof can result in increased fines and penalties. 

Here’s what the two OCR documents require:

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Department of Health and Human Services,Government Perspectives,HHS

HHS awards over $87 million for health centers’ IT enhancements

Today, Health and Human Services (HHS) Secretary Sylvia M. Burwell announced more than $87 million in funding for 1,310 health centers in every U.S. state, the District of Columbia, Puerto Rico, the Virgin Islands and the Pacific Basin.

“Health centers across the country are instrumental in providing high-quality, comprehensive primary health care to millions of people,” said Secretary Burwell. “This investment will help unlock health care data and put it to work, improving health outcomes and building a better health care system for the American people.”

The funding will support health information technology enhancements to accelerate health centers’ transition to value-based models of care, improve efforts to share and use information to support better decisions, and increase engagement in delivery system transformation. To support these goals, all purchases or upgrades of electronic health record systems made with the funding must use technology that is certified by the Office of the National Coordinator for Health Information Technology. This is the first significant investment since 2009 directly awarded to health centers to support the purchase of health information technology. 

“These awards will allow health centers to deliver higher quality of care to patients and spend health care dollars in a smarter way,” said Jim Macrae, Health Resources and Services Administration (HRSA) Acting Administrator. 

Nearly 1,400 health centers operating over 9,800 sites provide care to more than 24 million people across this nation, in every U.S. state, the District of Columbia, Puerto Rico, the Virgin Islands and the Pacific Basin. Today, health centers employ nearly 190,000 people.

This funding comes from the Affordable Care Act’s Community Health Center (CHC) Fund, which was extended with bipartisan support in the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015. The increased use of health information technology is part of the administration’s efforts to build a health care system that delivers better care, smarter spending and healthier people.

For a list of these fiscal year 2016 Delivery System Health Information Investment Awards recipients, visit: http://bphc.hrsa.gov/programopportunities/fundingopportunities/dshii/fy2016awards/index.html

To learn more about HRSA’s Health Center Program, visit: http://bphc.hrsa.gov/about/index.html

To find a health center in your area, visit: http://findahealthcenter.hrsa.gov/

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Centers for Medicare & Medicaid Services,CMS,communications,disaster,Government Perspectives

CMS finalizes rule to bolster emergency preparedness of certain facilities participating in Medicare and Medicaid

Today, the Centers for Medicare & Medicaid Services (CMS) finalized a rule to establish consistent emergency preparedness requirements for health care providers participating in Medicare and Medicaid, increase patient safety during emergencies, and establish a more coordinated response to natural and man-made disasters.

Over the past several years, and most recently in Louisiana, a number of natural and man-made disasters have put the health and safety of Medicare and Medicaid beneficiaries – and the public at large – at risk. These new requirements will require certain participating providers and suppliers to plan for disasters and coordinate with federal, state tribal, regional, and local emergency preparedness systems to ensure that facilities are adequately prepared to meet the needs of their patients during disasters and emergency situations.  

“Situations like the recent flooding in Baton Rouge, Louisiana, remind us that in the event of an emergency, the first priority of health care providers and suppliers is to protect the health and safety of their patients,” said CMS Deputy Administrator and Chief Medical Officer Patrick Conway, M.D., MSc. “Preparation, planning, and one comprehensive approach for emergency preparedness is key. One life lost is one too many.”

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Cerner,HealtheEDW,HealtheIntent,HealtheRegistries,LACDHS,Los Angeles County Department of Health Service,PRIME Project

LA County Department Of Health Services selects Cerner’s population health management platform

The Los Angeles County Department of Health Services (LACDHS), in collaboration with the California PRIME Project (1115 MediCal waiver), has expanded its relationship with Cerner, a global leader in health care technology, to implement its population health management platform, HealtheIntent. LACDHS is Cerner’s 100th HealtheIntent client.

HealtheIntent is a source-agnostic, near real-time population health management platform designed to aggregate and normalize data from multiple sources. The platform is designed to enable thousands of LACDHS clinicians to make more informed decisions by providing a comprehensive profile of an individual and the entire population. This comprehensive profile can be used to proactively identify gaps in care and analyze population and enterprise data through use of HealtheRegistries and HealtheEDW, Cerner’s registries and scorecards and enterprise data warehouse solutions.

“Our goal is to improve the health of the community that DHS serves, moving it to the highest standard possible,” said Dr. Robert Bart, chief medical information officer, LACDHS. “Cerner has established a standardized and integrated countywide EHR system to support the delivery of high-quality care, and we’re confident that the addition of Cerner’s population health management expertise will help us continue to reach our goals.”

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ASPR,Assistant Secretary for Preparedness and Response,BARDA,Biomedical Advanced Research and Development Authority,Centers for Innovation in Advanced Development and Manufacturing,CIADM,Department of Health and Human Services,Government Perspectives,HHS,Moderna Therapeutics,mRNA,vaccine,Zika

HHS accelerates development of mRNA-based Zika vaccine

The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) today announced an $8.2 million contract award to Moderna Therapeutics of Cambridge, Massachusetts, to help speed the development of a novel vaccine to prevent the spread of the Zika virus. 

ASPR’s Biomedical Advanced Research and Development Authority (BARDA) will provide technical assistance, oversight, and funding to advance the Zika vaccine’s clinical development. 

Under the initial 4-year agreement, BARDA will support a Phase 1 clinical trial, toxicology studies, vaccine formulation, and manufacturing. If additional funding is identified the agreement could be extended up to a total of five years and a total of $125.5 million to support Phase 2 and 3 clinical trials, as well as large scale manufacturing. All of this work is required for the company to apply to the U.S. Food and Drug Administration for vaccine licensure.

“BARDA is taking a three-pronged approach to combat Zika, developing vaccines, diagnostics, and technologies that will protect the blood supply. Today’s agreement with Moderna expands and diversifies our portfolio of candidate vaccines and improves our chances of having a vaccine to provide protection to people and halt the spread of the Zika virus,” said Dr. Richard Hatchett, acting director of BARDA.

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Department of Health and Human Services,Government Perspectives,HHS,Office of the National Coordinator for Health Information Technology,ONC

ONC announces Blockchain challenge winners

The Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology (ONC) today announced the winners of the Use of Blockchain in Health IT and Health-related Research Challenge.  A Blockchain – most commonly associated with digital currency – is a data structure that can be timed-stamped and signed using a private key to prevent tampering.  ONC received more than 70 submissions from a wide range of individuals, organizations and companies addressing ways that Blockchain technology might be used in health and health IT to protect, manage, and exchange electronic health information.

“We are thrilled by the incredible amount of interest in this challenge,” said Vindell Washington, M.D., M.H.C.M., national coordinator for health IT. “While many know about Blockchain technology’s uses for digital currency purposes, the challenge submissions show its exciting potential for new, innovative uses in health care.”

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Centers for Medicare & Medicaid Services,CMS,Government Perspectives,market place,sterring

CMS examines inappropriate steering of people eligible for Medicare or Medicaid into Marketplace plans

The Centers for Medicare & Medicaid Services (CMS) today issued a request for information seeking public comment on concerns that some health care providers and provider-affiliated organizations may be steering people eligible for, or receiving, Medicare and/or Medicaid benefits into Affordable Care Act-compliant individual market plans, including Health Insurance Marketplace plans, for the purpose of obtaining higher reimbursement rates. CMS also sent letters to all Medicare-enrolled dialysis facilities and centers informing them of this announcement.

The request for information and letters to providers focus on situations where patients may be steered away from Medicare or Medicaid benefits, which can among other concerns, result in beneficiaries experiencing a disruption in the continuity and coordination of their care as a result of changes to their network of providers. These actions reflect ongoing efforts by the CMS Center for Program Integrity to address possible issues in the Marketplace that could affect the integrity of the programs for both consumers and issuers, and the costs of the individual insurance market, while at the same time help ensure patients are enrolled in the right plan for them.

“Ensuring access to high quality patient care is a top priority for us. We are concerned about reports that some organizations may be engaging in enrollment activities that put their profit margins ahead of their patients’ needs,” said CMS Acting Administrator Andy Slavitt. “These actions can limit benefits for those who need them, potentially result in greater costs to patients, and ultimately increase the cost of Marketplace coverage for everyone.”

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Department of Health and Human Services,Government Perspectives,health centers,HHS

HHS awards more than $100 million to improve health center quality

Today, the U.S. Department of Health and Human Services announced more than $100 million to 1,304 health centers in all 50 states, the District of Columbia, the 5 U.S. territories and the 3 Freely Associated States to invest in health center quality improvement, building upon their achievements in providing high quality comprehensive care. Health centers will use these funds to expand current quality improvement systems and infrastructure and to improve primary care service delivery in the communities they serve.

“Millions of Americans rely on health centers to provide them with quality health care,” said Dr. Mary Wakefield, HHS Acting Deputy Secretary. “These quality improvement awards will support health centers to continue to deliver superior health care that engages patients, improves care coordination and bridges overall access to care.”

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BARDA,Biomedical Advanced Research and Development Authority,Department of Health and Human Services,Government Perspectives,HHS,Hologic,Zika,Zika virus

HHS awards $4.1 million to Hologic to develop better Zika blood screening test

Today, the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response announced a $4.1 million agreement with Hologic, of Marlborough, Massachusetts, to advance the development of a blood screening test that will help detect the presence of Zika in the blood supply.  

This is the second blood screening test ASPR’s Biomedical Advanced Research and Development Authority (BARDA) is helping advance that may be used to test donated blood for Zika. In April, ASPR announced support of a clinical study of a Zika blood screening test developed by Roche Molecular Systems, of Branchburg, New Jersey, to confirm whether that test accurately detects the virus in donor blood.

“Accurate blood-screening tools are vital to protecting our nation’s blood supply from Zika. This test may provide another tool laboratories can use to identify infected blood donations to help ensure patients’ safety,” said Dr. Richard Hatchett, BARDA’s acting director. “At the same time, we are pursuing promising diagnostic tools, and vaccines to identify and prevent Zika virus infections.”

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Advocate Health Care Network,Department of Health and Human Services,Government Perspectives,Health Insurance Portability and Accountability Act,HHS,HIPAA

Advocate Health Care settles potential HIPAA penalties for $5.55 million

Advocate Health Care Network (Advocate) has agreed to a settlement with the U.S. Department of Health and Human Services, Office for Civil Rights (OCR), for multiple potential violations of the Health Insurance Portability and Accountability Act (HIPAA) involving electronic protected health information (ePHI). Advocate has agreed to pay a settlement amount of $5.55 million and adopt a corrective action plan.  This significant settlement, the largest to-date against a single entity, is a result of the extent and duration of the alleged noncompliance (dating back to the inception of the Security Rule in some instances), the involvement of the State Attorney General in a corresponding investigation, and the large number of individuals whose information was affected by Advocate, one of the largest health systems in the country. 

“We hope this settlement sends a strong message to covered entities that they must engage in a comprehensive risk analysis and risk management to ensure that individuals’ ePHI is secure,” said OCR Director Jocelyn Samuels. “This includes implementing physical, technical, and administrative security measures sufficient to reduce the risks to ePHI in all physical locations and on all portable devices to a reasonable and appropriate level.”

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