News & Analysis as of September 22, 2024

Cybersecurity › 21st Century Cures Act

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Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk... more +

Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk management, global regulations, data protection, leaks, hacking, cyber insurance, compliance, HIPAA, and every other aspect of cybersecurity of import to corporate readers right now. less -

[Event] Healthcare Privacy Compliance Academy - July 15th - 18th, Charlotte, NC

Health Care Compliance Association (HCCA) on 3/13/2024

Ideal for professionals with some compliance knowledge and experience, HCCA’s Healthcare Privacy Compliance Academy offers practitioners a deeper understanding of effective compliance management in a healthcare setting. The...more

Data Privacy Day: 15 Tips to Keep in Mind for the Coming Year

Fox Rothschild LLP on 1/25/2023

Data Privacy Day is this weekend. Here are some tips and pointers individuals and businesses should keep in mind going forward. 1. Transparency is front and center for regulators in the United States and Europe, so if...more

[Event] Regional Healthcare Compliance Conference - January 20th, Atlanta, GA

Health Care Compliance Association (HCCA) on 1/17/2023

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education, including updates on the latest news in regulatory...more

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Health Care Compliance Association (HCCA) on 2/17/2022

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

The Privacy Survival Guide - August 2021

Polsinelli on 8/9/2021

Virginia recently adopted a GDPR-inspired comprehensive data protection law for Virginia residents. What Are the Main Points Covered by Virginia’s Consumer Data Protection Act (CDPA)? ...more

A Look Ahead: US FDA And Medical Device Regulations In 2021

Lowenstein Sandler LLP on 3/11/2021

The pandemic year of 2020 presented FDA with many enormous challenges, including how to use emergency authorizations to approve diagnostic tests, personal protective equipment, and therapies, how to conduct remote...more

Arent Fox's Stark & Anti-Kickback Statute Final Rules Analysis

ArentFox Schiff on 3/3/2021

Click the link below for our complete analysis of recent updates to the Stark Law and Anti-Kickback Statute and their impact on health care providers. ...more

Stark and AKS Final Rules Will Facilitate Donations of EHR and Cybersecurity Technology and Services

McDermott Will & Emery on 12/23/2020

On November 20, 2020, the Centers for Medicare and Medicaid Services and Office of Inspector General released final rules amending the regulations to the Stark Law and the Anti-Kickback Statute and Beneficiary Inducement...more

Congress Passes Bill to Mitigate Penalties for Potential HIPAA Violations

WilmerHale on 12/23/2020

On December 19, the Senate passed H.R.7898, which the House of Representatives had previously passed on December 9. This law amends the Health Information Technology for Economic and Clinical Health (HITECH) Act to require...more

Report on Patient Privacy Volume 20, Number 11. Privacy Briefs: November 2020

Health Care Compliance Association (HCCA) on 11/11/2020

Report on Patient Privacy 20, no. 11 (November 2020) - HHS Office of the National Coordinator (ONC) for Health Information Technology (ONC) is giving health care organizations more time to meet new rules on information...more

Be Aware Before You Share: Vetting Third Party Apps Prior to Data Transfer

Epstein Becker & Green on 8/13/2020

As consumerism in healthcare increases, companies and the individuals they serve are increasingly sharing data with third-party application developers that provide innovative ways to manage health and wellness, among numerous...more

Regulatory Sprint: HHS Proposes Expansion of Protections for EHR and Cybersecurity Donations

Baker Donelson on 11/13/2019

In furtherance of its goals of expanding the adoption of electronic health records (EHR) and improving security through the use of cybersecurity technology, the Department of Health and Human Services (HHS) has proposed...more

HHS Proposes Sweeping Changes to AKS and Stark Law, Part 2: Cybersecurity Technology and Electronic Health Records

Mintz - Health Care Viewpoints on 10/22/2019

On October 17, 2019, the Department of Health & Human Services (HHS) published two proposed rules (one by the Office of Inspector General (OIG) and one by the Centers for Medicare & Medicaid Services (CMS)) that, if...more

2018 Digital Health Data Developments – Navigating Change in 2019

McDermott Will & Emery on 2/5/2019

Data privacy and security legislation and enforcement saw significant activity in 2018 and early 2019. McDermott’s 2018 Digital Health Year in Review: Focus on Data report – the first in a four-part series – highlights...more

HHS Releases Voluntary Cybersecurity Practices, Supplementing Existing Requirements

Burns & Levinson LLP on 1/16/2019

At the close of 2018, the Department of Health and Human Services (HHS) published Health Industry Cybersecurity Practices (HICP): Managing Threats and Protecting Patients. While not formally styled as guidance or interpretive...more

FDA 2018 Year in Review (and a Few Thoughts on 2019)

Mintz - Health Care Viewpoints on 12/31/2018

As 2019 quickly approaches, we would like to take a few moments to reflect on the past year of Food and Drug Administration activities and certain big ticket items that made news in 2018. As the Magic 8-Ball would say: “signs...more

FDA Strives to Adapt Regulatory Approach to Rapidly Evolving Digital Health Space

Skadden, Arps, Slate, Meagher & Flom LLP on 6/20/2018

Just two months after taking office, in July 2017, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced the agency’s Digital Health Innovation Action Plan, which recognized that “digital technology has...more

On the Digital Health Frontier: Developments Driving Industry Change in 2018

McDermott Will & Emery on 1/26/2018

As digital health innovation continues to move at light speed, both new and incumbent stakeholders find themselves on a new frontier—one that challenges traditional health care delivery and payment frameworks, in addition to...more

Trump Administration: 2017 Recap and 2018 Outlook

Akin Gump Strauss Hauer & Feld LLP on 1/17/2018

On January 20, 2017, businessman Donald J. Trump was sworn in as the 45th President of the United States following a contentious and unconventional 2016 presidential election. Republicans also successfully maintained control...more

Digital Health Year in Review: 2017 Trends and Looking Ahead to 2018

McDermott Will & Emery on 1/10/2018

Introduction - Throughout 2017, the health care and life science industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and...more

Bah, Humbug! HIPAA Compliance Isn’t Getting Any Easier

Mintz - Health Care Viewpoints on 12/22/2017

As we look back on 2017, one message is clear: don’t be a Scrooge when it comes to HIPAA compliance. With ever-evolving security threats and unrelenting enforcement, regulated entities must maintain a spirit of compliance...more

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