Consumer Protection Health

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Hong Kong Commissioner upgrades rules for processing biometric data

The Hong Kong Commissioner has published guidance (‘Guidance’) to assist data users in complying with Hong Kong’s privacy laws when processing biometric data, and takes a broader approach than previous guidance dealing with...more

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

Canadian Government to Ban Microbeads in Personal Care Products

Microbeads are synthetic polymer particles manufactured to be larger than 0.1 micrometer and smaller than or equal to five millimeters and are commonly used in personal care products such as scrubs, bath products, facial...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

FTC Urges FDA to Reconsider Homeopathic Regulatory Framework

In a comment filed last Friday, the Federal Trade Commission (FTC) responded to its sister-agency’s request for comments by urging the Food and Drug Administration (FDA) to reconsider how homeopathic drugs are regulated. As...more

CFPB Orders Subsidiary of Peer-to Peer Lending Company to Provide $700,000 in Restitution over Practices Related to its Health...

On August 19, the CFPB announced a consent order against a subsidiary of an online lending company, ordering the subsidiary to provide $700,000 in monetary relief to affected consumers. According to the CFPB, the subsidiary...more

FTC Resolves Case Against “Melanoma Detective” App Marketer

The FTC announced late last week that it resolved its case against the final defendant, Avrom Lasarow, in the “Melanoma Detective” app matters. The FTC alleged that claims that the apps could detect and diagnose melanoma in...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

CFPB enters into consent order with company charged with deceptive health care credit enrollment practices

The CFPB has entered into a consent order with Springstone Financial, LLC to settle charges that the company was responsible for alleged deceptive and misleading acts and practices in connection with enrolling consumers in 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

Antitrust Issues Facing Physicians in Medicaid and Professional Licensing

Physicians who were practicing in the 1990s were involved in numerous attempts to organize themselves in order to be able to participate in and even financially survive the onslaught of managed care delivery systems. The new...more

Ruling on Economic Favoritism Puts ‘NC Dental’ Back in Spotlight

In a recent opinion, a divided panel of the U.S. Court of Appeals for the Second Circuit ruled that an economic regulation passed by a state agency solely to protect one group from competition would not violate the...more

Privacy Tuesday – August 2015: Three Bytes for End of Summer

It’s Privacy Tuesday again – and summer is winding down. Here are three bytes of privacy/security information to start your week...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

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