Searching Content by Sarah Beth S. Kuyers ordered by Published Date Descending.
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OIG Reports Focus On Hospice Quality Of Care
Earlier this month, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) released two reports regarding its concerns and recommendations
United States
31 Jul 2019
New Guidance For Business Associates And Continued Data Breaches
The HHS Office for Civil Rights (OCR) released a new guidance document regarding which HIPAA violations business associates (BAs) can and cannot be held directly liable for.
United States
18 Jun 2019
Maryland Legislature Passes Bill Allowing Direct Advertising Of Certain Laboratory Tests
The Maryland General Assembly recently passed a bill that permits any person to directly or indirectly advertise diagnostic laboratory tests in the state, with certain limitations.
United States
30 Apr 2019
Secretary Azar Addresses Drug Pricing And Care Coordination In AHLA Keynote
Earlier this week, Alex Azar, Secretary of the Department of Health and Human Services ("HHS"), delivered keynote remarks at AHLA's 2019 Institute on Medicare and Medicaid Payment Issues.
United States
4 Apr 2019
Latest HIPAA Breach Involves Medical Records Hack Of Business Associate
Regular readers of the blog won't be surprised to hear that there has been another data breach, this time involving a business associate in charge of storing medical records on behalf of health care
United States
15 Mar 2019
A Tale Of Two False Claims Act Settlements Involving EHR Vendors
Last week the Department of Justice (DOJ) announced a $57 million settlement with electronic health record (EHR) software vendor Greenway Health LLC (Greenway).
United States
19 Feb 2019
45 States Now Have Biosimilar Substitution Laws
Forty-five states and Puerto Rico have now enacted laws that permit or require pharmacists to dispense an interchangeable biological product in certain situations.
United States
18 Feb 2019
HIPAA And Health Care Data Privacy - 2018 Year-In-Review
Today, we're looking back at HIPAA and other privacy and security developments in 2018. This past year saw continued HIPAA enforcement ...
United States
10 Jan 2019
Some BPCIA Clouds Begin To Clear: FDA Issues Final Plans For March 2020 "Deemed To Be A License" Provision
In his typical forceful style on December 11, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced several big pieces of policy news affecting the nascent biosimilar market.
United States
2 Jan 2019
Another HIPAA Settlement For Failure To Enter Into A BAA
Last week, the Office for Civil Rights announced that it had reached a settlement with a contract physician group based in Florida to resolve potential HIPAA violations relating to the sharing of PHI with a vendor.
United States
14 Dec 2018
Changes Ahead For HIPAA?
As we discussed last week, the Department of Health and Human Services (HHS) recently published its semi-annual regulatory agenda.
United States
6 Nov 2018
OCR Warns Providers About Securely Disposing Electronic Devices
The July 2018 cyber security newsletter issued by the U.S. Department of Health and Human Services' Office for Civil Rights reminds health care providers and their business associates of the importance ...
United States
16 Aug 2018
Privacy And Security Round-Up – Colorado Data Breach Law, Guidance From OCR
Privacy and security compliance obligations for health care companies remain hot topics this spring.
United States
22 Jun 2018
OCR Highlights Importance Of Physical Safeguards To Protect PHI
The May 2018 cyber security newsletter from the U.S. Department of Health and Human Services Office for Civil Rights (OCR) focused on a topic often overlooked by covered entities...
United States
1 Jun 2018
Mintz Levin Health Care Qui Tam Update
•We identified 56 health care related qui tam cases that were unsealed in October and November 2017.
United States
23 Mar 2018
HIPAA Enforcement Survives Closure Of Business
The U.S. Department of Health and Human Services OCR recently announced a $100,000 settlement with a company that is no longer in business. Filefax, Inc. was an Illinois company that provided storage and...
United States
28 Feb 2018
Mintz Levin's Health Care Enforcement Defense Group Releases New Qui Tam Update
This Update analyzes the 47 health care-related qui tam cases unsealed in August and September 2017.
United States
9 Feb 2018
Bah, Humbug! HIPAA Compliance Isn't Getting Any Easier
As we look back on 2017, one message is clear: don't be a Scrooge when it comes to HIPAA compliance. With ever-evolving security threats and unrelenting enforcement ...
United States
27 Dec 2017
Fifth Circuit Limits FCA Liability Due To Lack Of "Materiality" In Highway Guardrails Case
Earlier this week we released a Health Care Enforcement Advisory about a recent decision from the U.S. Court of Appeals for the Fifth Circuit that may have a significant impact ...
United States
4 Dec 2017
Fifth Circuit Decision in Highway Guardrails Case Provides Important Guidance on Materiality in False Claims Act Cases
The U.S. Court of Appeals for the Fifth Circuit recently decided a case that could have a substantial impact on False Claims Act ("FCA") jurisprudence with respect to the element of "materiality."
United States
30 Nov 2017
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