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
An estimated 350,000 out-of-hospital cardiac arrest deaths occur each year in the U.S. Approximately 10% of those who experience out-of-hospital cardiac events survive. Use of automated external defibrillators (AED), however,...more
As we all try to keep up with the Metaverse and as the healthcare system wilts under a data deluge, the convergence of realities in a shared online space is not merely a chance for practitioners and patients to find each...more
The surge in new health apps and connected devices, which only increased during the pandemic, continues to raise many legal and ethical questions. As a result, lawmakers have been scrambling to define the obligations...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
On September 22, the U.S. Food and Drug Administration (FDA) announced the launch of its Digital Health Center of Excellence within the Center for Devices and Radiological Health. The FDA called this an important step toward...more
The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) recently unveiled a new website with updated guidance and resources for mobile health app developers regarding the HIPAA Privacy, Security, and...more
The U.S. Department of Health and Human Services (HHS) and Department of Justice (DOJ) have released the 2019 annual report for their Health Care Fraud and Abuse Control Program. The government recovered almost $3.6 billion,...more
Manufacturers of activity trackers and smartwatches have been fighting over the “serious” healthcare market for several years. Companies such as Apple (previously discussed here), Fitbit (previously discussed here), and...more
The Digital Planning Podcast is designed to educate individuals about all things digital in connection with estate planning, business planning and estate administration. Your hosts, Jennifer Zegel, Ross Bruch and Justin...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
On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement discretion policies in light of the 21st Century Cures Act (Cures Act). The...more
Most people are familiar with blockchain technology because of its use in cryptocurrency, but its use is going to be far more widespread than just as a ledger for digital currency. As explained in a previous blog post,...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
Cisco Talos has discovered a new menace to iPhone users—a sophisticated malware campaign targeting iPhones to trick users into downloading an open-source Mobile Device Management (MDM) solution that gives the hackers control...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
The Situation: Artificial intelligence is being used in innovative ways in the health care industry to drive down costs and improve clinical outcomes. The Issue: The health care industry, including the provision of health...more
On January 4, 2018, the National Health Information Sharing and Analysis Center (NH-ISAC) posted an announcement regarding the cybersecurity threats Meltdown and Spectre that were recently identified....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
Recently, digital currencies, such as bitcoin, have greatly increased in popularity. Some of this popularity may be attributed to digital currencies’ many purported advantages over traditional currencies, such as that...more
The Food and Drug Administration (FDA) issued guidance yesterday (September 6, 2017) entitled “Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices,” which is intended to “assist...more
There are more than 165,000 mobile health applications available for download in Apple’s App Store or Google Play. This number will likely keep rising, and a body of federal and state regulators, including state attorneys...more
On April 24, 2017, the Department of Health and Human Services, Office of Civil Rights (“OCR”), announced its first settlement with a wireless health services provider, CardioNet, Inc., for alleged violations of the Health...more
The U.S. Food and Drug Administration (FDA) issued on July 27, 2016, a draft guidance document addressing how it may use data and evidence collected outside of the traditional clinical trial context to support medical device...more
The Vulnerability of Healthcare Information - According to a report the Brookings Institute issued in May 2016, 23% of all data breaches occur in the healthcare industry. Nearly 90% of healthcare organizations had some...more
At a recent public workshop, Dr. Janet Woodcock, director of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), announced plans to expand the agency’s use of the Sentinel...more