Tag Archives: health law

ILN Today Post

CAUTION FOR PHYSICIANS DURING COVID-19

As COVID-19 cases surge, medical regulators are taking swift action to ensure that drugs required to treat the virus are prescribed based on evidence, and that they remain available to patients who need them. A directive was issued this week from the Ontario Pharmacists Association, Ontario Medical Association, and Registered Nurses’ Association of Ontario, which can be found here. The Directive reminds medical professionals of their obligation to educate patients that treatments for COVID-19, like with any illness, need to be evidence based. Read the full article.

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FDA Guidance Clarifies HDE Program Review

Earlier this month, the FDA released programmatic guidance intended to clarify the current review practices for the Humanitarian Device Exemption (“HDE”) Program (“Guidance”) reflecting recent changes in the HDE Program resulting from statutory amendments made by the 21st Century Cures. The Guidance addresses frequently asked questions about FDA actions on HDE applications, post-approval requirements, and includes a filing checklist to clarify the required information for the FDA to consider whether an HDE application is ready for substantive review.

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Part 2 Rule Update Modernizes SUD Record Disclosure Regulations

On January 3, 2018 the Substance Use and Mental Health Services Administration (SAMHSA) published a final rule implementing new changes to the Confidentiality of Substance Use Disorder Patient Records, 42 C.F.R. part 2 (Part 2). The Part 2 privacy regulations govern the confidentiality of substance use disorder (SUD) patient records which are maintained in connection […]

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Changes to Washington’s Pregnancy and Leave Laws

Accommodation of Pregnant Employees Effective July 23, 2017, employers in Washington State with 15 or more employees must provide specific reasonable accommodations for pregnant employees.  Undue hardship is not an excuse for some of the accommodations, including: Providing more frequent, longer, or flexible restroom breaks Modifying a no food or drink policy Providing seating or […]

The post Changes to Washington’s Pregnancy and Leave Laws appeared first on OMW Health Law.

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Healthcare Mobile Device Encryption: Is It Required?

Encryption of mobile device technology has become essential in the eyes of the OCR.  Although HIPAA treats encryption as an “addressable” safeguard –as opposed to a “required” safeguard— under the Security Rule, the following OCR settlements involving unencrypted mobile devices indicate that encryption is obligatory for HIPAA compliance. As new technologies emerge and the use […]

The post Healthcare Mobile Device Encryption: Is It Required? appeared first on OMW Health Law.

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Failure to Provide Communication Aide Costs Hospital $20K

John Dempsey Hospital agreed to pay $20,000 as compensation to a patient after failing to provide auxiliary communication aids during an emergency department visit. The patient, who is deaf and uses American Sign Language for communication, had to rely on a companion for all treatment communications.  In addition to paying compensation to the patient, the […]

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Texas Injunction on Modifications to “Exempt” Status May Affect WA Healthcare Employers

The Department of Labor’s (the “DOL”) new rule related to the salary-level test for exempt employees was challenged yesterday in a broad ruling from the Eastern District of Texas.  Yesterday, a federal judge in the Eastern District of Texas issued a nationwide preliminary injunction against the DOL rule which increased the salary-level test for exempt […]

The post Texas Injunction on Modifications to “Exempt” Status May Affect WA Healthcare Employers appeared first on OMW Health Law.

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MACRA Released

On Friday, CMS released the MACRA final rules, its innovative payment system for Medicare replacing the sustainable growth rate formula and the EHR Incentive Program for Medicare providers. MACRA creates the framework for providers to participate in the CMS Quality Payment Program through either the Advanced Alternative Payment Models (Advanced APMS) or the Merit-based Incentive […]

The post MACRA Released appeared first on OMW Health Law.

For more information please visit www.omwhealthlaw.com or click on the headline above.

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HIPAA Audit Program Phase II – Have You Been Selected?

Phase II of the HIPAA Audit Program has begun, with many covered entities and business associates receiving a “Audit Entity Contact Verification” message from the Department of Health and Human Services (HHS) and the Office of Civil Rights (OCR). The communication requires the individual recipient to verify that he or she is the primary contact […]

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Can non-MSSP ACOs qualify for Tax-Exempt Status?

The Internal Revenue Service (IRS) recently affirmed its decision to deny 501(c)(3) tax-exempt status to an accountable care organization (ACO) that did not participate in the Medicare Shared Savings Program (MSSP). The IRS initially denied the ACO’s request for tax exempt status in a determination letter dated August 25, 2014. While neither the determination letter […]

The post Can non-MSSP ACOs qualify for Tax-Exempt Status? appeared first on OMW Health Law.

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