Category Archives: Health Care Law

Guidance on Ransomware Attacks under HIPAA and State Data Breach Notification Laws

On July 28, 2016, US Department of Health and Human Services (HHS) issued guidance (guidance) under the Health Insurance Portability and Accountability Act (HIPAA) on what covered entities and business associates can do to prevent and recover from ransomware attacks. Ransomware attacks can also trigger concerns under state data breach notification laws. What Is Ransomware? …

Read more »

Pokémon Go – Staying Ahead of Game and Avoiding Unexpected HIPAA Risks

It was inevitable – Pokémon Go fever has swept the nation, and now little cartoon creatures have found their way into your health care facility. Wait, what!? Yes, you read that right, those pesky (or beloved, depending on your point of view) creatures are popping up literally everywhere, and unfortunately hospitals and other health care …

Read more »

EEOC Alleges Hospital’s Mandatory Flu Vaccine Policy Violates Title VII

As summer temperatures soar, one might think the last thing to worry about is the upcoming flu season. And while that may be true in most respects, the flu is on the minds of the Equal Employment Opportunity Commission (EEOC). A lawsuit filed by the EEOC sheds light on the issue for healthcare employers who …

Read more »

Senate Judiciary Introduces CREATES Act To Expedite Access To Affordable Drugs

Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced legislation targeting “behavior that blocks competition and delays the creation of affordable generic drugs” and biosimilar products. The bill, entitled the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016, S. 3056, would punish the strategic …

Read more »

FDA Releases Draft Guidance for Manufacturers on Dissemination of Patient Data from Medical Devices

On June 9, 2016, the US Food and Drug Administration (FDA) published draft guidance outlining considerations for the “appropriate and responsible” dissemination of individualized data from medical devices from device manufacturers to patients. In the draft guidance, FDA clarifies that medical device manufacturers may share “patient-specific information” from legally marketed medical devices with patients at …

Read more »

Informed Consent and Health Information Security Essential: New American Medical Association Guidelines for Telemedicine

On June 13, 2016, the American Medical Association (AMA) approved new ethical guidelines pertaining to the appropriate use of audio-video technologies to connect with and treat patients remotely. Through these guidelines, the AMA advocates for greater use of telemedicine by physicians while concomitantly encouraging such providers to inform patients regarding the limitations of any technology, …

Read more »

False Claims Act: DOJ Appealing AseraCare Loss

On May 27, 2016, the US Department of Justice said it will appeal to the Eleventh Circuit its loss in the False Claims Act (FCA) case against hospice chain AseraCare Inc. The government’s decision to appeal comes as no surprise, and it means that the substantial attention this case has received will continue. As a …

Read more »

american medical association

OCR Continues to Verify Entity Contact Info for Phase 2 HIPAA Audits

Covered Entities need to continue to check their inboxes for emails from the HHS Office for Civil Rights (“OCR”) requesting verification of contact information in connection with Phase 2 of the HIPAA Audit Program. OCR previously indicated that Covered Entities would begin to receive verification emails in May.  We understand that Covered Entities continue to …

Read more »

FDA Outlines Future Medical Device Coordinating Center

The federal Food and Drug Administration’s planning board (Planning Board) for a medical device evaluation system (NMDES) recently recommended the creation of a centralized Coordinating Center to develop a national system to evaluate medical devices. Convened in 2014 by the U.S. Food and Drug Administration and the Brookings Center for Health Policy, the Planning Board emerged …

Read more »

doctor, tablet

Ohio Following National Trend in Clarifying Permissible Telemedicine Activities

On April 15, 2016, the State Medical Board of Ohio (Ohio Board) released proposed rules outlining the requirements for practitioners to prescribe or cause a prescription drug to be provided to a person who is at a location remote from the practitioner and for whom the practitioner has never conducted a physical examination. The proposed …

Read more »