November 27, 2014
| Digital Healthcare > Regulatory Policy

Regulatory Policy


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Health Care & Health-IT Under Obama Digital HealthCare & Productivity | WASHINGTON—The election of Barack Obama as president and the solidification of the Democratic majority in Congress clearly will have an effect on the national health care agenda for 2009, but some of the reasons might not be so obvious.

Health IT Certification Moves Forward Digital HealthCare & Productivity | WASHINGTON—The American Medical Informatics Association (AMIA) is turning its attention to medical specialty boards in its bid for recognition of clinical informatics as a distinct medical subspecialty, following the approval of detailed plans for physician informatician training and competency.

Fed Report Calls on NIH to Blaze Personalized Medicine Trail Digital HealthCare & Productivity | It’s a busy time on the personalized medicine front. The recently-released federal government report, Priorities for Personalized Medicine, is gradually attracting attention. The state of Wisconsin last week jumped into the race to become a center for personalized medicine. And a group of technology providers has joined Scripps Translational Science Institute (STSI) to study to what extent people make behavioral changes when they are provided with genetic screening and information about their various risk factors.

Certifying PHRs Digital HealthCare & Productivity | The first set of certification criteria for personal health records (PHRs) products will focus more on privacy, security, and interoperability with other health-IT and less on specific functionality in an effort to foster innovation in a relatively new market segment, according to the Certification Commission for Healthcare Information Technology (CCHIT).

CCHIT Certifies EHRs and HIEs Digital HealthCare & Productivity | On Tuesday, CCHIT said that eight ambulatory electronic health records (EHR) products earned full certification under the new 2008 criteria for interoperability. Tomorrow, CCHIT will open the first-ever application period for certification of health information exchanges (HIE).

Warfarin Test: Who Should Pay for Personalized Medicine? Digital HealthCare & Productivity | Payers, physicians, and the pharmaceutical industry are closely watching CMS deliberations over whether or not to pay for a genetic-based test that provides guidance on Warfarin dosing. The FDA, which approved the test, says it’s an important tool, but the CMS isn’t so sure and opened a National Coverage Analysis (NCA) on the subject in August.

Privacy Certification Program Aims to Ensure Patients’ Trust Digital HealthCare & Productivity | A former senior advisor in the Department of Health and Human Services (HHS) is heading up the first large-scale effort to certify health-IT products for adherence to privacy standards.

Lively Debate at HIPAA Summit at Harvard Digital HealthCare & Productivity | Are patient privacy rules effective? The answer is not a simple yes or no. “It’s working, but it’s got a ways to go,” suggests William Braithwaite, chief medical officer of San Diego-based security and identity management company Anakam.

Karen Trudel of CMS Talks about HIPAA Audits and NPI Issues Digital HealthCare & Productivity | In the wake of one of the largest fines levied by HHS for a HIPAA (Health Insurance Portability and Accountability Act) violation, HIPAA official Karen Trudel says to expect further audits and enforcement proceedings as federal officials begin to extend compliance reviews.

Security Features Not Limited to Paper Digital HealthCare & Productivity | Electronic prescribers who want to print prescriptions for Medicaid patients no longer will have to spend up to 10 times the cost of plain paper to comply with new tamper-resistance regulations, the result of intense negotiations between government officials, medical societies, the pharmacy industry, paper manufacturers, and two health-IT advocacy groups.

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Life Science Webcasts & Podcasts

medidata_podcast_Sites and Sponsors: Mending Bridges over Troubled Waters  
Sites and Sponsors: Mending Bridges over Troubled Waters
Sponsored by Medidata Solutions Worldwide

This podcast brings together two industry leaders to focus on the issues that divide sponsors and sites. On the one hand sites and sponsors unite in advancing better health care through a common passion for developing better drugs. Yet some issues divide them and bridges need to be built or mended to advance the highest levels of cooperation, coordination and success in clinical trials. Listen as the key issues are debated from the site and the sponsor side and new methods and technology are advanced that offer near-term and lasting solutions.

• Common ground in reaching agreement on a budget

• Improving the pace of agreement on budgets and contracts

• Processes for payment to sites on a timely basis

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