Science, Computers & Technology Health

Read Science, Computers & Technology updates, news, alerts, and legal analysis from leading lawyers and law firms:
News & Analysis as of

Health Update - August 2016

Section 1332 Waivers: Will We See More State Innovation? - Editor's Note: In a new essay for the National Institute of Health Care Management (NIHCM), summarized below, Manatt Health examines Section 1332 waivers and the...more

Missouri Governor Signs New Telemedicine Law

Missouri’s governor signed into law SB 579 (the “Act”), on June 8, 2016, establishing new telemedicine practice standards, including explicitly allowing a valid physician-patient relationship to be established via...more

OCR to Investigate More HIPAA Breaches Affecting Fewer Than 500 Individuals

On August 18, 2016, the U.S. Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) announced plans to expand its investigations of reported breaches of the Health Insurance Portability and...more

Health Care E-Note - August 2016

The Alabama Natural Death Act contains the provisions on how an individual may plan for end-of-life decisions. Specifically, it outlines the requirements for a valid Advanced Directive and the removal and withdrawal of life...more

OIG Highlights Varying Local Medicare Part B Drug Coverage Policies; Recommends Single Entity to Make Drug Coverage Determinations

The OIG has issued a report entitled “MACs Continue to Use Different Methods to Determine Drug Coverage,” which reviews how Medicare Administrative Contractors (MACs) make Medicare Part B drug coverage determinations and...more

GAO Calls For Mandatory Medicare Drug ASP Reporting, CMS Verification of Drug Pricing

A recent Government Accountability Office (GAO) report, “Medicare Part B: CMS Should Take Additional Steps to Verify Accuracy of Data Used to Set Payment Rates for Drugs,” questions the reliability of pricing for Medicare...more

Manatt on Health Reform: Weekly Highlights - August 2016 #4

HealthCare.gov plans an open enrollment pilot that will let consumers compare provider network breadth; new Medicaid enrollees reduce out-of-pocket spending on prescription drugs by nearly 60%; and Kansas’s Governor announces...more

HIPAA Security Rule Compliance for Providers & Business Associates in Three Easy Steps

On August 4, 2016, the Office for Civil Rights (“OCR”) of the U.S. Health & Human Services Department (“HHS”) announced a $5.55 million HIPAA settlement with Advocate Health Care Network (“Advocate”), the largest...more

The Marijuana Industry’s Big Win: The DEA’s Refusal to Reschedule

Earlier this year, when the U.S. Drug Enforcement Agency (DEA) indicated it would have an announcement regarding a now five-year-old petition to reschedule cannabis, numerous industries on the “outside looking in” were...more

What's in a Name? A Quick Guide to Biologic Drug Names

We have previously reported on the complicated naming issues surrounding biosimilar products and how biological qualifiers, such as three or four-letter codes, should be added to distinguish between them. However, the...more

Update in Janssen v. Celltrion: Parties Stipulate that Celltrion Will Not Sell Remicade Biosimilar Before October 3, 2016

In a stipulation filed yesterday in Janssen v. Celltrion, Celltrion has agreed not to sell its Remicade biosimilar in the U.S. for use by doctors or patients before October 3, 2016, and the parties have agreed to dismiss all...more

Defending a Data Breach Investigation by the Federal Trade Commission

Your company has experienced a data breach, and the Federal Trade Commission (“FTC”) notifies you that it is initiating a non-public investigation. How the company responds can significantly affect the course of the...more

HIPAA Phase 2 Audits: What Has OCR Requested from Auditees to Date?

In our April 8, 2016, advisory, we discussed the U.S. Department of Health and Human Services’ (HHS) Office of Civil Rights (OCR) “Phase 2” audit program. Then, we could only make educated guesses about what documents OCR...more

Review Published of Nanomaterials for Products and Application in Agriculture, Feed, and Food in the European Union

The European Food Safety Authority (EFSA) requested a review of the already marketed and in-development applications of nanomaterials in the agri/feed/food sectors. The results of the review are published in the August 2016...more

HRSA Proposes Administrative Process to Resolve Disputes Between 340B Program Covered Entities and Drug Manufacturers

Taking a step toward completing a requirement imposed by the Affordable Care Act, the federal government has proposed regulations that would create an administrative dispute resolution (“ADR”) process to resolve disputes...more

Heal Thyself: Insider Threats to Heed, Especially for Industries with Large Amounts of Personal Information

A recent study by the Ponemon Institute found that insider threats due to malicious or negligent employees are the leading cause of private-sector cybersecurity incidents. Of the over 600 information security professionals...more

Hackers Steal 600K Records from Health Care Firms – Could Your Wearable Device Be Next?

Security firm InfoArmor published a report in late July 2016 stating that a group of attackers infiltrated American health care institutions, stole at least 600,000 patient records and attempted to sell more than 3 terabytes...more

Healthcare Records Held Hostage: When ransomware attacks

Imagine for a moment that your hospital or physician practice suddenly cannot access its electronic medical records. There hasn’t been a natural disaster. No, instead you are inexplicably staring at a computer screen from an...more

AGG Food and Drug Newsletter - August 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Celltrion Begins Shipping Remsima to the U.S.

As we reported last week, the district court granted Celltrion’s Motion for Summary Judgment of Invalidity for one of the two patents-at-issue in Janssen v. Celltrion. The Korea Times reports that Celltrion shipped its...more

A Closer Look at the OCR’s Guidance on Ransomware

In the wake of several high-profile ransomware infections targeting hospitals and health care organizations, the Department of Health and Human Services Office for Civil Rights (OCR) has issued guidance on the growing threat...more

New FDA Draft Guidance Helps Define the Scope of §510(k) Medical Device Preemption

Earlier this month the FDA issued a draft guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device.” It’s long, and anyone interested in reviewing the whole thing can download it from the FDA’s...more

Texas Medical Board’s Appeal Must Proceed Under Existing Jurisdiction Arguments

In another procedural defeat for the Texas Medical Board (the “Board”) over its embattled telemedicine rule, last week, a federal judge held that the Board waited too long to request certification of appeal to the Fifth...more

OCR Plans to More Widely Investigate HIPAA Breaches Affecting Fewer than 500 Individuals

This month the HHS Office for Civil Rights (OCR) has launched an initiative “to more widely investigate the root causes” of HIPAA breaches affecting fewer than 500 individuals, according to an August 18, 2016 OCR email...more

3.3 Million Health Records Breached by Business Associate Newkirk

Newkirk Products Inc., which provides ID cards and management services for healthcare organizations, including multiple Blue Cross Blue Shield organizations, has announced that it has discovered that its computer system was...more

4,623 Results
|
View per page
Page: of 185

Follow Science, Computers & Technology Updates on:

JD Supra Readers' Choice 2016 Awards

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×