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Krysten Rosen Moller practices in the areas of health care, litigation, pharmaceutical investigations, and white collar defense and investigations. Ms. Rosen Moller primarily helps pharmaceutical and medical device companies with internal investigations, and civil and criminal investigations by the DOJ, FDA, HHS, and other agencies, relating to fraud, marketing, kickbacks, manufacturing practices, and false claims. Ms. Rosen Moller also provides advice on developments in, and compliance with, health care laws.

On January 22, 2016, the Centers for Medicare & Medicaid Services (“CMS”) announced the launch of a new, streamlined application process for providers and hospitals seeking a hardship exception from financial penalties for failing to meet meaningful use electronic health record requirements.   According to CMS, “[t]he streamlined hardship applications reduce the amount of information that . . . must be submit[ted] to apply for an exception.”
Continue Reading CMS Launches Streamlined Application for Meaningful Use Hardship Exceptions

Last week, the chairmen and ranking members of the Senate Committee on Health, Education, Labor, and Pensions and the Senate Committee on Finance sent a letter to Andy Slavitt, Acting Administrator for the Centers for Medicare & Medicaid Services (“CMS”), and Jocelyn Samuels, Director of the Health and Human Services (“HHS”) Office for Civil Rights (“OCR”), requesting information on how HHS “is working to support and protect victims of medical identity theft” in order to “assess the adequacy of current efforts.”
Continue Reading Senators Request Information from HHS About Medical Identity Theft Efforts

In a 107-page report, released last week, the White House set forth its plan to create and manage a database containing 1 million or more Americans’ medical records in furtherance of the Precision Medicine Initiative. As announced by President Obama during his 2015 State of the Union Address, the Precision Medicine Initiative was launched “to bring us closer to curing diseases like cancer and diabetes, and give all of us access to the personalized information we need to keep ourselves and our families healthier.”

To achieve this goal, the Precision Medicine Initiative Cohort Program (“PMI-CP”) will build a “research cohort” of at least 1 million volunteers, which will provide the “platform” for improved understanding and knowledge of precision medicine approaches. As explained in the report, “[p]recision medicine is an approach to disease treatment and prevention that seeks to maximize effectiveness by taking into account individual variability in genes, environment, and lifestyle.”
Continue Reading Report Outlines Plan for Precision Medicine Database

The National Cybersecurity Center of Excellence (“NCCoE”) has released a draft for public comment of the first guide in a new series of publications “that will show businesses and other organizations how to improve their cybersecurity using standards-based, commercially available or open-source tools.” The guide discusses how to secure electronic health records on mobile devices. “The draft guide was developed by industry and academic cybersecurity experts, with the input of health care providers who first identified the challenge.”
Continue Reading Comments Requested on Draft Guide on Securing Electronic Health Records on Mobile Devices

On May 28, 2015, a panel from the American Medical Informatics Association (“AMIA”) published an eleven-page “Report of the AMIA EHR 2020 Task Force on the Status and Future Direction of EHRs.”  Recognizing that current problems in EHR use “are complex” and that “[s]olving these problems will require regulatory stability, the development of an acceptable threshold ‘barrier to entry’ into the EHR marketplace, and a supportive national policy,” the report outlines ten “near-term strategies” to address challenges with EHR systems.   
Continue Reading American Medical Informatics Association Report Makes Recommendations for EHR Systems

In a recently released Data Brief, the Office of the National Coordinator for Health Information Technology (ONC) described trends in adoption of Basic EHR and certified EHR in non-federal acute care hospitals from 2008 to 2014.  “Basic EHR represents a minimum use of core functionality determined to be essential to an EHR system.”  “A certified EHR is EHR technology that meets the technological capability, functionality, and security requirements adopted by the Department of Health and Human Services.”  Data cited in the brief are from the American Hospital Association (AHA) Information Technology (IT) Supplement to the AHA Annual Survey.

The Data Brief identifies and discusses four trends.
Continue Reading ONC Data Brief Describes Positive Trends in the Adoption of EHR Systems

A study published in the March 2015 issue of Communications of the ACM (Association for Computing Machinery) revealed that 91% of health-related websites initiated some type of HTTP request (HTTP is a request/response protocol, by which, for example, a computer sends a request for a file and the web server sends back a response) to third parties and that approximately 70% of those requests included sensitive information about specific symptoms, treatments, or diseases.
Continue Reading Study Finds That Majority of Health-Related Websites Share Personal Information With Third-Parties

On December 8, 2014, the U.S. Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology (ONC) issued the Federal Health IT Strategic Plan 2015-2020.  “The Strategic Plan represents a coordinated and focused effort to appropriately collect, share, and use interoperable health information to improve health care, individual, community and public health, and advance research across the federal government in collaboration with private industry.”  In developing the Strategic Plan, ONC collaborated with more than 35 federal agencies.
Continue Reading Federal Health IT Strategic Plan 2015-2020 Open for Comment