Health Care Counsel

Arent Fox's health care law blog offers news, analysis, and insights for the health care industry.

Health Care Counsel
HIPAA / Health Privacy & Security
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Business Associates Beware! HHS Levies First HIPAA Fines on Business Associate

On June 24, 2016, the non-profit Catholic Health Care Services of the Archdiocese of Philadelphia (CHCS) agreed to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule with the U.S. Department of Health and Human Services (HHS). This is HHS’ first resolution agreement and monetary penalty against a business associate (BA) under HIPAA.
 

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HIPAA / Health Privacy & Security
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Beware of Ransomware, Or the Bad Guys Could Hold Your Devices and Data Hostage

What’s New?

Ransomware is old news – it has been around at least since 1989 – but it has only now started to attract widespread attention. Ransomware is a type of malicious software (or malware, for short) that blocks access to the infected device, to some or all of the information stored in the device, or even worse, to files in the device’s network. To unlock either the device or the data, the responsible cybercriminals require the victim to pay a ransom. Ransomware is typically enabled when a victim clicks on malicious links in an email or online.
 

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E-Health, HIPAA / Health Privacy & Security, mHealth, Telemedicine & E-health
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Approval of Privacy Shield Provides Framework for Transfer Personal Data between the US and EU

What’s New?

After months of negotiations, it’s official: the EU-US Privacy Shield has been formally approved on both sides of the Atlantic, by the EU Commission and the US Commerce Department, despite concerns surrounding the adequacy of its earlier version.

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E-Health, HIPAA / Health Privacy & Security, mHealth
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IT Systems Put Security into Health Care Cybersecurity

*This article was originally published by The Journal of Health Care Compliance.

Strong cybersecurity is no longer an option for health care institutions. A medical chart is identity theft on a platter. Criminals pay more for personal health information than for credit card numbers. Unauthorized access to electronic health records surpassed hacking as the chief cybersecurity risk in 2016. Third-party information technology (IT) systems used by heath care providers and other institutions (referred to for convenience as “hospitals” in this article) are a key avenue of unauthorized access and pose a significant risk as hospitals upgrade IT systems either alone or as part of a merger into larger health care systems. This article address how health care IT puts the security in health care cybersecurity.

Seven Critical Cybersecurity Roles Played by IT

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E-Health, HIPAA / Health Privacy & Security
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OCR’s HIPAA Guidance on Ransomware Expands Traditional Interpretation of “Breach”

On Monday, July 11, 2016, the Office for Civil Rights (OCR) released a fact sheet with guidance for covered entities and business associates on HIPAA and ransomware.

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Hospitals and Acute Care
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Proposed Rule May Significantly Cut Reimbursement To Existing Hospital Off-Campus Outpatient Clinics Beyond Congressional Intent

On July 6th, CMS released a proposed rule (expected to appear in the Federal Register on July 15th) that, if it takes effect, could be devastating to hospital off-campus outpatient department reimbursement – an effect not intended by Congress, and certainly unwelcome to the healthcare industry.

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False Claims Act, Fraud & Abuse Compliance
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Don't Have a Heart Attack...but Enforcement Scrutiny Increasing Against Some Cardiac Care Providers

* The following alert was originally published in California Healthcare News (CHN). To read it on the CHN website, click here.

There are reports of breakthrough healthcare treatments virtually every day. Heart disease – one of the leading causes of death in the United States – is no exception. Through advances in technology and other factors, certain life-saving procedures, which in the past could only be performed in the hospital setting, are now routinely performed at thousands of stand-alone surgery centers specializing in cardiac care which have cropped up throughout the country. Recently, state and federal authorities have taken action against some of these surgery centers, as well as hospitals, demanding a cessation of practice or refusing to provide reimbursement on a variety of grounds.

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E-Health, HIPAA / Health Privacy & Security, mHealth, Telemedicine & E-health
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What Do Self-Driving Cars and Your Heart Monitor Have in Common? The Same Questions About Cybersecurity.

Arent Fox partner Sarah Bruno recently published a very interesting alert on new privacy and cybersecurity challenges facing the automotive industry in the age of autonomous vehicles, syncing software, and wearable devices that interact with your vehicle. What does this have to do with the health care industry, you ask? Both the automotive industry and the health care industry are among the largest in the United States. And both industries are the focus of rapid technology development that raise similar, complicated questions about data privacy and security, especially as those technologies increasingly interact with each other. 

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Pharmaceutical & Device Compliance, Prescription Drug Pricing & Government Price Reporting, Wholesaler & Pharmacy Benefits Compliance
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CMS Releases Covered Outpatient Drug Final Rule FAQs

On July 6, CMS issued a set of Frequently Asked Questions to respond to questions raised by the Covered Outpatient Drug Final Rule that was published on February 1, 2016.  The FAQs can be accessed here; our January 28 article analyzing the final rule can be accessed here and our analysis of the delayed implementation of the revised 5i AMP methodology and 70/30 test can be found here.

For more information regarding the Covered Outpatient Drug Final Rule, please contact Stephanie Trunk or Erin Atkins in our Washington, DC office or the Arent Fox attorney who regularly handles your matters
 

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Arent Fox LLP, founded in 1942, is internationally recognized in core practice areas where business and government intersect. With more than 350 lawyers, the firm provides strategic legal counsel and multidisciplinary solutions to clients that range from Fortune 500 corporations to trade associations. The firm has offices in Los Angeles, New York, San Francisco, and Washington, DC.