The Health Insurance Portability and Accountability Act of 1996 was enacted by the United States Congress and signed by President Bill Clinton in 1996. It has been known as the KennedyKassebaum Act or Kassebaum-Kennedy Act after two of its leading sponsors. Title I of HIPAA protects health insurance coverage for workers and their families when they change or lose their jobs. Title II of HIPAA, known as the Administrative Simplification (AS) provisions, requires the establishment of national standards for electronic health care transactions and national identifiers for providers, health insurance plans, and employers.
HIPAA Compliance: Protecting your patients health information is more difficult and more important than ever. HIPAA rules have been adopted which pertain to all Protected Health Information (PHI) including paper and electronic, as well as dealing specifically with Electronic Protected Health Information (EPHI).
Envoy Data has gone to great lengths to design-in solutions that are HIPAA compliant, and ready to easily be added to your existing infrastructure and make your company compliant with these government mandates.
The HITECH Act (Health Information Technology for Economic and Clinical Health Act) requires entities covered by the HIPAA to report data breaches, which affect 500 or more persons, to the United States Department of Health and Human Services (U.S.HHS), to the news media, and to the people affected by the data breaches.
- CMS Proposes to Cancel Bundled Payment and Incentive ModelsThe U.S. Centers for Medicare & Medicaid Services (CMS) published a proposed rule last week regarding the cancellation of three bundled payment models and an incentive payment model while also reducing the scope of a third type of payment model. These models were mandatory for hospitals in certain geographic areas. The current administration had delayed the... […]
- District Court Finds Hospital’s Joint Venture Not “Per Se” UnlawfulOn the eve of trial, and after years of litigation (including an appeal to the Sixth Circuit), all claims by Dayton, Ohio hospital The Medical Center at Elizabeth Place (“MCEP”) against Premier Health Partners (“Premier”) have been dismissed with prejudice. This case represents an important development in the body of case law addressing the antitrust risk introduced by... […]
- The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 4Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion. Not surprisingly, FDA has taken a hard-line approach in its guidance on off-label communications, similar to the Agency’s forceful January 2017 memo. This aggressive stance... […]
- CMS May Decide to Permit Labs to Bill for Certain Tests Provided to OutpatientsIn the recently published proposed rule related to the CY 2018 Hospital Outpatient Prospective Payment System (OPPS), the Centers for Medicare & Medicaid Services (CMS) announced that it is considering changes to the regulation governing the date of service (DOS) for clinical laboratory and pathology specimens. The DOS rules are important to laboratories and hospitals because they dictate which party must... […]
- Mintz Levin’s Health Care Enforcement Defense Group Publishes New Qui Tam UpdateLast week, Mintz Levin’s Health Care Enforcement Defense Group published a new Qui Tam Update, which analyzes 21 health care-related False Claims Act qui tam cases unsealed in May 2017, and the findings include: long delays in unsealing remain the norm; relators overwhelmingly consisted of current and former employees (and physicians); and the most common alleged... […]
- Holdout States Loosen Restrictions on Telemedicine but Obstacles RemainA few months ago, two states that previously imposed onerous telemedicine requirements – Texas and Oklahoma – enacted laws that loosen restrictions on telemedicine providers and generally fall into line with what a vast majority of states already permit. However, these laws continue a pattern in which each state’s telemedicine laws use different definitions for... […]
- Mintz Levin Attorney Discusses FDA’s Digital Health Innovation PlanOur colleague Bethany Hills recently discussed the Food and Drug Administration’s Digital Health Innovation Plan, which sets forth the agency’s new approach to regulating digital health. Her discussion appears in a FierceHealthcare article published earlier this week entitled “9 Companies Will Play a Huge Role in Shaping the FDA’s Novel Approach to Digital Health.” The full... […]
- August 2017 Is Here – Will FDARA Get Done Soon?It has been some time since we provided a detailed update on the status of FDA’s user fee legislation making its way through Congress, so that’s what is on tap for today. The House passed the lengthy FDA Reauthorization Act (FDARA) on July 13, 2017 as H.R. 2430, and House members have now left Washington,... […]
- Health Care Weekly Preview from ML Strategies – Week of July 31, 2017Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of July 31, 2017. This week’s preview focuses on the fallout from the failed vote to repeal the Affordable Care Act (ACA), including the issue of whether the federal government will continue to pay cost-sharing reduction subsidies (CSRs), as well a new proposal by... […]
- The HIPAA “Wall of Shame” is Now Easier to NavigateLast week, the HHS Office for Civil Rights (OCR) launched an improved version of their HIPAA Breach Reporting Tool (HBRT), commonly referred to by OCR and regulated entities alike as the HIPAA “Wall of Shame.” OCR has also made minor changes to the interface for breach reporting. The HBRT now makes it easy to navigate... […]