The Federal Trade Commission (“FTC”) recently issued guidance clarifying protections applicable to consumers’ sensitive personal data increasingly collected by so-called “health apps.” The FTC press release indicated it has approved a policy statement by a vote of 3-2 offering guidance
Continue Reading FTC Warns That Health Apps May Be Subject to the Health Breach Notification Rule
On September 30, 2021, the Provider Reimbursement Review Board (the “Board”) issued a revised set of rules that become effective November 1, 2021. These new and revised rules affect all new and some pending Medicare Part A provider appeals. These
Continue Reading PRRB Updates Its Rules and Mandates Electronic Filing
In this column, in the coming months we are going to dig into the data regarding FDA regulation of medical products, deeper than the averages that FDA publishes in connection with its user fee obligations. For many averages, there’s a
Continue Reading Unpacking Averages: FDA Review Time for 510(k)s
In this episode of the Diagnosing Health Care Podcast: On December 27, 2020, President Trump signed into law the No Surprises Act as part of the $2.3 billion Consolidated Appropriations Act. Recently, the Biden administration issued its first interim final
Continue Reading Podcast: No Surprises Act: Considerations for Plans and Providers – Diagnosing Health Care
Starting in 2022, Ohio will require owners of tax-exempt real property to notify the county auditor if the exempt property ceases to qualify for exemption.
This is a substantial departure from current law, which had left the role of monitoring
Continue Reading Charitable Health Systems and Other Owners of Tax-Exempt Property with Operations in Ohio Should Prepare for Upcoming Changes to Real Property Tax Exemption Laws
The New Jersey Department of Health (the “Department”) recently finalized regulations initially proposed in April 2020 that will now require all telehealth organizations providing telemedicine services to patients located in New Jersey to register their business with the Department before
Continue Reading Navigating New Jersey’s Telemedicine Business Registry
On Tuesday, August 24, 2021, California Attorney General Rob Bonta issued a guidance bulletin (the “Guidance”) to health care providers reminding them of their compliance obligations under California’s health data privacy laws, and urging providers to take proactive steps to
Continue Reading Under Pressure: California Clarifies Cyber Risk Management Best Practices for Healthcare Sector
On August 30, 2021, the DOJ announced a $90 million dollar settlement with Sutter Health and affiliates[1] (“Sutter Health”) to settle False Claims Act (“FCA”) allegations brought by qui tam relator, Kathy Ormsby, related to the Center for Medicare
Continue Reading The Department of Justice (“DOJ”) Continues its Medicare Advantage (“MA”) Enforcement Efforts with a $90 Million Dollar Settlement Against Downstream Provider Sutter Health
On June 21, 2021, Florida Governor Ron DeSantis signed into law a bill requiring genetic counselors to be licensed by the Florida Department of Health (“FLDOH”). The new law, known as the Genetic Counseling Workforce Act (“GCWA”), became effective on
Continue Reading Florida Joins a Growing Number of States Requiring Licensure of Genetic Counselors
In this episode of the Diagnosing Health Care Podcast: Although the COVID-19 pandemic exposed cybersecurity vulnerabilities across sectors, it has particularly challenged the resilience of information systems for health care and life sciences companies. Because ransomware attacks have the
Continue Reading Podcast: How Can Companies in the Health Care and Life Sciences Industries Strengthen Their Cybersecurity Posture? – Diagnosing Health Care
