Podcast: Discussing Information Blocking with Eddie Williams
Podcast: Keeping an Eye on HIPAA Trends with Shannon Hartsfield
A Zero Percent Error Rate: An Inspiring Story on How to Get There
Expanded Information Block Rules Go into Effect
Podcast: Interoperability: Information Blocking Claims and Enforcement - Diagnosing Health Care
Podcast: Interoperability: Health Care's Next Disruptor Is openEHR - Diagnosing Health Care
Podcast: Interoperability: A New Vision Through openEHR - Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Podcast | Episode 99: David Stefanich, Co-founder and CEO, Rymedi
Podcast: Interoperability - the Role of Health Information Exchanges - Diagnosing Health Care
Gerry Blass on Healthcare Vendor Risk Management
Hooper, Kearney and Macklin on Cutting Edge Topics in the False Claims Act
AGG Talks: Technology - In the Balance: Interoperability and Security
The New Information Blocking Rule: What It Means For Hospices
Sitting with the C-Suite: Looking Ahead to Potential Compliance Issues Due to COVID-19
From NC State to Changing the State of Health Information Networks, with Medicom Technologies’ Malcolm Benitz
Exploring Digitization of Health and Medical Data and Records Part Two
Exploring Digitization of Health and Medical Data and Records Part One
Patient Records Requests: What You Need to Know
Electronic Medical Records: Help or Hindrance?
Technology in Healthcare
As part of the Real-World Evidence Program, the U.S. Food and Drug Administration (FDA) has released the final guidance, “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory...more
The Food and Drug Administration (FDA) has issued new draft guidance, Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products (the “External Controls Draft Guidance”), that...more
On November 1, 2022, Modernizing Medicine, Inc. (“ModMed”), an electronic health record (“EHR”) technology vendor, entered into a settlement agreement with the Department of Justice (“DOJ”), agreeing to pay $45 million to...more
While the pandemic put many things on hold, it did not do the same for the False Claims Act (FCA). To find out what is happening in FCA activity we spoke with Patrick Hooper, Jordan Kearney and Alicia Macklin, partners at the...more
On November 20, 2020, the US Department of Health and Human Services (HHS) released final rules amending the regulations to the physician self-referral law (Stark Law) (Stark Rule) and the Anti-Kickback Statute (AKS) and...more
Amazon recently introduced the Halo fitness tracker, its first entry into the health wearables market currently dominated by Fitbit and the Apple Watch. Amazon’s previous efforts to move into the healthcare industry have...more
On January 27, 2020, the Department of Justice (DOJ) announced a $145 million settlement with electronic health record (EHR) vendor Practice Fusion to resolve civil and criminal allegations that it violated the Anti-Kickback...more
A software developer of an electronic health records system utilizing AI is the recent target in a DOJ fraud investigation. On January 27, 2020, the DOJ announced that Practice Fusion, Inc. entered into a deferred...more
In the DOJ’s first-ever criminal action against an electronic health records vendor, San Francisco-based Practice Fusion Inc. agreed to pay $145 million to resolve allegations that it received kickbacks from pharmaceutical...more
On January 27, 2020, the Department of Justice (DOJ) announced a $145 million settlement with Practice Fusion Inc., an electronic health records (EHR) software company, that resolves parallel criminal and civil investigations...more
Based on their extensive experience advising health care industry clients, Epstein Becker Green attorneys and strategic advisors from EBG Advisors are predicting the “hot” health care sectors for investment, growth, and...more
This episode is the first in a series focusing on recent efforts by the Substance Abuse and Mental Health Services Administration (SAMHSA) to update 42 C.F.R. Part 2 (Part 2) regulations related to the confidentiality of...more
Blockchain technology originated in 1991, and was conceived as a secure way to timestamp digital documents akin to how a notary timestamps physical documents. The true value lies in the fact that once stamped, the document...more
Clinical trials in the EU include the collection of sensitive health data from patients. Trial sponsors are obliged to reconcile their respect of regulations governing data protection with regulations governing the conduct of...more
...Alexander: Senate Sends Opioids Legislation Called “Landmark” by Leader McConnell to President – On Wednesday, the U.S. Senate passed by a vote of 98-1, the SUPPORT for Patients and Communities Act, sponsored by Senator...more
A confluence of factors is increasing and accelerating the digitization of large amounts of real world data (RWD) generated on individuals and patients. Originally published in Update magazine - August/September 2018....more
The conduct of clinical trials still relies heavily on the use of paper documents. Of course, electronic case report forms (eCRF) have been commonly used for many years – the medical information on a patient that is...more
A pilot program that could improve the efficacy of medication therapy management (MTM) services among Medicare Advantage (MA) beneficiaries would present minimal risk to federal health care programs and patients, according to...more
On December 11, 2017, the Health and Human Services Office of Inspector General (OIG) posted a favorable Advisory Opinion, permitting a proposed pilot Program involving a collaboration between a pharmaceutical manufacturer...more
This is our third installment in our series about the legal issues involved in launching a health app, which the U.S. Food and Drug Administration (“FDA”) refers to as “mobile apps.” The goal of this post is to provide you...more
It’s Spring! In this issue of Pro Te, we do a little a “spring cleaning” to brush the dust off some familiar topics that we consider in day-to-day pharmaceutical litigation. In The Forgotten Element? Warnings Proximate...more
The Department of Health & Human Services Office of Inspector General (OIG) recently issued a favorable advisory opinion regarding an electronic health record vendor’s plan to provide services to hospitals to help manage...more