Science, Computers & Technology Health

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

FDA Regulatory and Compliance Monthly Recap

Mobile health industry could get a boost as FDA draft guidance exempts certain medical devices, including digital health devices - The FDA’s decision to not require a number of mobile health devices to go through the...more

Wrap-Up of Federal and State Chemical Regulatory Developments (September 2014)

Health Activists' Petition Seeks Sunset Of CBI Claims: On August 21, 2014, six environmental health organizations filed a petition under Section 21 of the Toxic Substances Control Act (TSCA). The petition urges the U.S....more

September 22, 2014 – HIPAA Compliance Deadline for Business Associate Agreements Is Just Around the Corner

All business associate agreements (“BAAs”) must be updated and compliant with current Health Insurance Accountability and Portability Act (“HIPAA”) regulations by September 22, 2014. Failure to meet this deadline could result...more

Deadline to Update Business Associate Agreements for HIPAA is Approaching

The deadline for updating your health plan’s existing business associate agreements is rapidly approaching. The final regulations issued on January 25, 2013 under the Health Insurance Portability and Accountability Act...more

China’s NHFPC issues Opinions on Promotion and Administration of Telemedicine Services

In recent years, China’s central government has made substantial investments to support the development of telemedicine. According to statistics from the National Health and Family Planning Commission (NHFPC), there were...more

Drug-Device Apple Cart Upset Again

On September 9, 2014, in Prevor v. Food and Drug Administration, the D.C. District Court held against FDA's interpretation of the definition of a medical device included in the Federal Food, Drug and Cosmetic Act (the act)....more

Health Care Update - September 2014 #2

In This Issue: - National Health IT Week Begins Today - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional and State Initiatives - Other Health Care...more

A New Sheriff in Town: Federal Trade Commission Enforcement of Medical Information Security

A recent court decision found that the Federal Trade Commission (FTC) has authority to enforce the requirements for security of Protected Health Information, or PHI, as defined under the Health Information Portability and...more

340B Federal Drug Pricing Program September Update: Self-Disclosures

As part of its ongoing series of monthly 340B Federal Drug Pricing Program (340B Program) integrity updates, the Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA) released an update on...more

California Court Dismisses CMIA Claim Based on Possession of Stolen Medical Data

A health organization narrowly averted paying a potential $4 billion in damages under the California Confidentiality of Medical Information Act (CMIA) for losing the medical records of more than 4 million patients. Plaintiffs...more

NIST Issues Draft Report Enumerating Risks and Protections to Consider When Evaluating Mobile Apps for Your Enterprise

As the world recovers from the excitement leading up to Tuesday’s Apple Live Event announcement of the new iPhone 6 and Apple Watch, mobile app developers are chomping at the bit to create software that leverages the new...more

OCR Reveals Information about Upcoming HIPAA Audits

At the Healthcare Information and Management Systems Society (“HIMSS”) Privacy and Security Forum this week, health information privacy senior advisor for the Office for Civil Rights (“OCR”) Linda Sanches revealed certain...more

Data protection authority investigates eHealth and wellness/fitness apps

eHealth and fitness/wellness applications are being investigated and potentially sanctioned by the Italian data protection authority that found half of them not compliant with applicable privacy laws....more

The Trend of Stricter State Data Breach Laws Continues with Florida

Florida’s new Florida Information Protection Act, Fl. Stat. § 501.171, became effective July 1, 2014. The new law repeals and replaces Florida’s existing data breach notification requirements (Fl. Stat. § 817.5681) with more...more

DEA Authorizes Take-Back Programs for Pharmacies

The U.S. Drug Enforcement Administration (DEA) recently issued a Final Rule expanding the facilities that can collect unused prescription drugs to now include retail pharmacies, hospitals and pharmaceutical manufacturers, as...more

PGR Report -- The Attack of 35 U.S.C. § 112

Last week, on September 2, 2014, Accord Healthcare, Inc. ("Accord") filed what appears to be the second-ever Post-Grant Review ("PGR") (see Petition). This PGR was for U.S. Patent No. 8,598,219 ("the '219 Patent"), which is...more

Court Report -- Part III: September 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Forest Laboratories LLC et al. v. Sigmapharm Laboratories LLC 1:14-cv-01119; filed September 3, 2014 in the District...more

Substitution allowed? State biosimilars laws are evolving

Biosimilar products have not yet reached the US market, but debates on the laws and regulations that will govern them have been raging for some time. It isn’t just federal law at issue. State law may have a profound impact as...more

FDA Publishes "Purple Book" for Biosimilars

FDA Publishes "Purple Book" to Catalog Biologics, Interchangeable and Biosimilar Products - The US Food and Drug Administration (“FDA”) recently published its first “Lists of Licensed Biological Products with Reference...more

Is Apple Leading a Health Management Revolution?

Yesterday was a significant day for Apple and its legions of loyal fans, but was it also the “beginning of a health revolution” as Apple alludes to? On September 9th, Apple announced its new iteration of the iPhone, the...more

Intellectual Property and Technology News - Issue 23, Q3 2014

In This Issue: - Substitution Allowed? State Biosimilar Laws Are Evolving - Patent Wars: Can The Energy Industry Avoid Them? - Surviving A Trademark Opposition Challenge: Do You Have A True...more

Federation of State Medical Boards Releases Interstate Licensure Compact

As previously reported by the team from ML Strategies, one of the many telehealth developments to watch this year has been the Federation of State Medical Board’s (FSMB) Interstate Licensure Compact. On September 5, the...more

Two-Party Market: Presumption of Confusion and Injury

Merck Eprova AG v. Gnosis S.p.A., et al. - Clarifying applicable presumptions in Lanham Act false advertising cases, the U.S. Court of Appeals for the Second Circuit affirmed a district court’s use of presumptions of...more

HEAL Advisory: Whistleblowers Rewarded Again by SEC and the Judiciary

On August 29, 2014, two whistleblower developments of particular interest to health care and life science entities emerged from the Securities and Exchange Commission ("SEC") and the Eighth Circuit Court of Appeals,...more

September 22, 2014: Quickly approaching deadline to amend business associate agreements

The HIPAA Omnibus Rule, enacted last year, made a number of changes to the HIPAA privacy, security and breach notification rules. Some of these changes affected business associate provisions of the HIPAA privacy and security...more

2,175 Results
|
View per page
Page: of 87

Follow Science, Computers & Technology Updates on: