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Read need-to-know updates, commentary, and analysis on Communications & Media issues written by leading professionals.

An Opportunity to Shape Compliance with GDPR

by Hogan Lovells on

A close observer of the GDPR will have noticed that, in several places, individual EU Member States can implement derogations from the GDPR requirements. Of course, as a regulation under EU law there is less scope for local...more

OCR Levies Hefty Fine Against FQHC

Showing no signs of letting up on enforcement actions, the Office for Civil Rights (OCR) late last week settled an investigation against Metro Community Provider Network MCPN, a Colorado based federally qualified health...more

OCR Urges Covered Entities and Business Associates to Use HTTPS

New guidance from the Office for Civil Rights (OCR) urges covered entities and business associates to use Secure Hypertext Transport Protocol (HTTPS) to protect communications from vulnerabilities. According to OCR, the...more

FDA Delays Effective Date of Amended Regulations Affecting "Intended Use" Definition

by Jones Day on

One day before the final rule, "Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding 'Intended Uses,'" would have taken...more

Washington University School of Medicine Victim of Phishing Attack

Another employee falls for a phishing attack. This time, it was an employee of the Washington University School of Medicine The employee received a phishing email on December 2, 2016, and feel for what looked like a real...more

Geotargeting Medical Facilities? Massachusetts Says ‘No Snoop For You!’

by Morgan Lewis on

Geotargeting—delivering content to users based on their geographic location—has become a popular and effective marketing tool. Yet proper implementation may be more nuanced than originally contemplated because certain...more

Securing Protected Health Information: FBI Warning

by Burns & Levinson LLP on

HIPAA and the HITECH are federal laws that require the protection and security of confidential, protected health information (PHI) and personally identifiable information that is not necessarily health related. The federal...more

Apple's Secret Team Working on Diabetes Solution Through Wearables

by Taylor English Duma LLP on

Yesterday's news about Apple's secret effort to find the 'holy grail' for treating diabetes is just the tip of the iceberg. The data-mining and communications solutions that are made possible by the Internet will...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 1

As 2017 began, FDA appeared poised to implement significant changes to the rules governing off-label communications related to drugs, biologics, and medical devices. The Agency had hosted a public hearing in November 2016 to...more

Ten Years of Conditional Marketing Authorizations

by Jones Day on

The European Medicines Agency ("EMA") published a report ("EMA report") concerning the data collected over 10 years—between July 2006 and June 2016—on the so-called "conditional marketing authorizations" ("CMAs")....more

Erie County Medical Center IT Systems Shut Down By Virus

Buffalo, New York Erie County Medical Center has announced that its IT system has been shut down since Sunday, April 11, 2017, due to an unnamed virus. The shut-down has affected the medical facility’s email system,...more

New York Attorney General Settles Claims against Three Health Apps

by Morgan Lewis on

Health app developers must be vigilant not only of federal laws, but of state laws as well. On March 23, New York Attorney General Eric T. Schneiderman announced a settlement with developers of three health-related...more

New York Attorney General Enters Digital Health App and Privacy Enforcement Fray: Announces Three Settlements with Health and...

by Ropes & Gray LLP on

On March 23, the New York Office of the Attorney General (“NY OAG”) announced Assurances of Discontinuance (“Settlements”) with three developers of health and fitness mobile apps. The Settlements appear to mark the NY OAG’s...more

Health Alert (Australia) April 10, 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 5 April 2017 - Reckitt Benckiser (Australia) Pty Ltd v Australian Competition and Consumer Commission [2017] HCASL 86 - The High...more

Mobile Health App Developers Under Fire for Misleading Claims and Irresponsible Privacy Practices

by Dechert LLP on

Mobile health apps are becoming more and more popular as a tool for consumers in maintaining healthy lifestyles. However, there is a growing concern that the health-related benefits are being over-stated by mobile health app...more

NY Attorney General Sanctions Highlight Need for Higher Standards for mHealth Research and Development

by McDermott Will & Emery on

On March 23, 2017, the New York Attorney General’s office announced that it has settled with the developers of three mobile health (mHealth) applications (apps) for, among other things, alleged misleading commercial claims....more

New York AG Takes Enforcement Action Against Heart Monitoring Apps: Murmurs of Concern are Heard in mHealth App World

In a move sure to cause murmurs in the large and growing mobile health application industry, the Office of New York Attorney General Eric Schneiderman (OAG) has used state trade laws to extract concessions and monetary...more

The TCPA: An Unexpected Deterrent to Patient Engagement Tools

by McDermott Will & Emery on

In an age where providers are increasingly taking the management of their patient’s health online and out of the doctor’s office, the creation of scalable and nimble patient engagement tools can serve to improve patient...more

Trump’s Nominee for FDA Commissioner Likely Dooms Generic Drug Labeling Rule

President Trump recently announced his intent to nominate a new commissioner of the U.S. Food and Drug Administration (FDA), likely sealing the fate of FDA’s proposed generic drug labeling rule. The proposed rule would give...more

NY AG Announces Settlements with Three Mobile-Health App Developers Over Privacy, Marketing Concerns

On March 23, 2017, New York State Attorney General Eric T. Schneiderman announced settlements with three mobile health application (app) development companies aimed at curbing deceptive marketing practices and inadequate...more

NY AG Targets Mobile Health Applications Over Privacy Policy, Misleading Claims Concerns

by Klein Moynihan Turco LLP on

The Office of the New York State Attorney General (“NY AG”) recently announced a settlement of its investigation into the privacy policy and advertising-related business practices of three popular health-based mobile...more

Tennessee Rule Change: Prohibition on Prescription Transfer Incentives

by Bass, Berry & Sims PLC on

Tennessee pharmacies can no longer offer patients financial rewards in exchange for the transfer of the patient's prescriptions. Effective February 20, 2017, the Tennessee Board of Pharmacy enacted a new rule providing that...more

Health Company Fined by UK’s Information Commissioner Office

by Hogan Lovells on

Last week, the UK’s Information Commissioner’s Office (ICO) published a monetary penalty notice which fined a private healthcare company, HCA International, £200,000 for its failure to keep sensitive data secure....more

Your Cyber Minute: Importance of the GDPR to the global business community [Video]

by Hogan Lovells on

Ambitious and broad-reaching, the Global Data Protection Regulation is impacting companies around the world. Listen as Partner Harriet Pearson and Head of our Privacy and Cybersecurity practice in Europe Eduardo Ustaran talk...more

Your Cyber Minute: Current GDPR regulatory and enforcement landscape  [Video]

by Hogan Lovells on

The conversation continues with Partner Harriet Pearson and Head of our Privacy and Cybersecurity practice in Europe Eduardo Ustaran as they go deeper into what clients need to know when it comes to compliance around the...more

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