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Back to School – HIPAA 101

After a summer that saw major data breaches at the Office of Personnel Management and UCLA Health System, this fall is a great time to take your organization back to school on HIPAA compliance and data security. Here are...more

State Pharmaceutical Pricing Disclosure Laws: Old Story, New Refrain

As a veteran of the AWP litigation era, I am struck by the recent state efforts to legislate transparency into pharmaceutical pricing. Multiple states have introduced bills that would require pharmaceutical manufacturers to...more

FTC Staff Comment Encourages FDA to Reevaluate its Current Approach to Regulating Homeopathic Products

On Friday, staff of the Federal Trade Commission’s Bureau of Consumer Protection, Office of Policy Planning, and Bureau of Economics submitted a written comment to FDA recommending that FDA reconsider its current regulatory...more

European Commission Seeking Comments On Draft Text Laying Out The Safety Features To Appear On Pharmaceutical Packaging

On 12 August 2015, the European Commission published its long awaited discussion draft of the European Union Delegated Act (EUDA) addressing safety features to appear on the outer packaging of medicinal products for human...more

China’s State Council Announces Reform on the Drug and Device Approval System

China will launch new reforms of its current review and approval system for drugs and medical devices, announced by China’s State Council, in its August 18, 2015, circular Opinions Concerning the Reform of the Review and...more

Mobile Health Devices and Cybersecurity: Federal Guidance for Management of Threats in Medical Devices

New Technology = New Threats - With new technology comes new security concerns. But when that new technology is in the medical field, the cybersecurity vulnerabilities can be particularly devastating. The...more

Six Ways for Data-Driven Medical Device Companies to Implement Effective Privacy and Security Measures

The increasing amounts of health information being generated, stored and collected have heightened the special risks medical device manufacturers have long faced. In addition to the nexus to patient health and safety, if a...more

Seventh Circuit rules hospital system is not a Consumer Reporting Agency under FCRA

Is a hospital a “consumer reporting agency”? Can a health care provider be liable under the Fair Credit Reporting Act (FCRA) in the event of a data breach? The Seventh Circuit Court of Appeals recently considered these...more

One Small Step for Amarin & One Giant Leap for Pharmaceutical Companies? - Only Time Will Tell

Friday’s ruling in Amarin Pharma, Inc. v. United States Food & Drug Administration is a monumental event. It signals the dawn of a new era for prescription drug promotion....more

FDA issues first medical device hacking alert

Reportedly for the first time ever, the FDA recently issued a declaration that hospitals should not use a medical device manufactured by Hospira Inc. because of security flaws that could allow hackers to penetrate hospital...more

HHS IT security found to be weak

The House of Representatives Energy and Commerce Committee issued a report late last week that the information security of the Department of Health and Human Services (HHS) has substantial weaknesses. Several incidents that...more

FDA's Cybersecurity Alert Puts Medical Device Users on Notice

On July 31, 2015, the United States Food and Drug Administration (FDA) issued a cybersecurity alert to health care facilities currently using certain infusion pumps manufactured by Hospira, Inc. The alert warns health care...more

Data processing company hit with class action lawsuit for data breach and Judge denies class certification the next day

Advanced Data Processing, Inc. and Intermedix Corp. were sued in federal court in Florida last week for violating the Health Insurance Portability and Accountability Act (HIPAA) for failing to protect the health information...more

Animal supplements still in limbo, facing increased FDA scrutiny

The thousands of food, agriculture and life sciences companies regulated by the federal government already face a barrage of complicated regulations. Add in significant regulatory uncertainty and a major reorganization of the...more

Second class action suit filed against Medical Informatics

We previously reported that Medical Informatics Engineering, Inc. was sued over a data breach that occurred in May and affected over 4 million individuals. Thereafter, Indiana AG Gregory Zoeller advised all Hoosiers to freeze...more

CareFirst BlueCross BlueShield sued for hacking incident

Not to be left out, plaintiffs filed suit against CareFirst BlueCross Blue Shield late last week for the hacking incident the insurer suffered in May, which resulted in unknown intruders gaining access to names, dates of...more

FDA Cites Drug Company for Kim Kardashian Endorsement

This week might have been the first time that an FDA regulatory issue hit the headlines on TMZ and other “celebrity watcher” websites. In an August 7 Warning Letter sent to the drug company Duchesnay, Inc., FDA complains...more

NIST Releases Draft Cybersecurity Practice Guide For Electronic Health Records

On July 22, the National Cybersecurity Center of Excellence (“NCCoE”), a U.S. government organization formed in 2012 within the National Institute of Standards and Technology (“NIST”), released a draft Cybersecurity Practice...more

New NIST Guide Advises Healthcare Companies on Securing Patient Health Information on Mobile Devices

In response to a growing demand for cybersecurity guidance in the health care industry, the National Institute of Standards and Technology (NIST), through its National Cybersecurity Center of Excellence, recently published a...more

Health Care Entities Get Clarity from FCC on Telephone Communications

The health care industry is in the midst of rapid change as governments fight rising health care costs, providers look to comply with myriad new regulations, and technology continues to take a more prominent role in the...more

NIST Issues Draft Guidance for Mobile Health Data

With health care breaches constantly on the rise, increasing access to electronic health records (EHRs) from mobile devices, and more prevalent “shadow” cloud use, health care organizations are getting a bit of help from the...more

Maine Welcomes Telemedicine with New Board Guidelines

The Maine Board of Licensure in Medicine enacted new guidelines governing the practice of telemedicine and the use of technology to deliver health care services. Effective June 2014, Maine’s guidelines expand upon prior Board...more

Guest Post - Just the Fax, Ma’am

While Bexis is on vacation, here is a guest post to take up some of the slack. Our guest blogger today is Henry Pietrkowski, a partner in Reed Smith's Chicago office. This one's a little different. It's about the impace of...more

FDA Regulation of Hospital-Developed Technologies - Hospital Industry Viewpoint

As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more

Class Action Suit Filed Against UCLA After It Suffers Massive Data Breach Affecting 4.5 Million Individuals

In yet another data breach affecting millions of individuals, UCLA Health System (“UCLA”) reported on July 17, 2015, that hackers had accessed portions of its health network that contained personal information, including...more

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