Health Science, Computers & Technology

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Hospital Text Messaging Rules Placed on Hold by Joint Commission

The Joint Commission, which accredits hospitals and other health care organizations, hit pause on its prior May 2016 announcement to allow secure text messaging in hospitals and other health care organizations. The use of...more

2.7 Million Dollar HIPAA Settlement

Last week, Oregon Health & Science University (“OHSU”) agreed to pay $2.7 million to resolve potential violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Security Rule, Privacy Rule, and...more

Breaking News: FTC Vacates ALJ’s Ruling and Finds LabMD Liable for Unfair Data Security Practices

In a ruling issued this morning, the Federal Trade Commission found that LabMD, the defunct Atlanta-based cancer detection lab, failed to protect patient information and is liable for unfair data security practices. The...more

Is Ransomware a Notifiable Data Breach Event?

There is no doubt that companies face unprecedented volume and variation in both disruptive and intrusive cyberattacks on their networks. Among the different attack methodologies today, ransomware is quickly becoming a major...more

FDA Approves Medtronic Prestige LP Cervical Disc for 2-Level Use

The FDA recently approved the Medtronic Prestige LP Cervical System for treating degenerative disc disease at two adjacent vertebral levels (between C3 and C7). The device is said to be Medtronic’s third clinically-proven...more

Two Multi-Million Dollar HIPAA Settlements Emphasize Importance of a Comprehensive Security Program

The U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) announced two settlements of more than $2 million each with respect to alleged violations of the Health Insurance Portability and...more

FDA Issues Draft Guidance as Part of Precision Medicine Initiative

The two draft guidance documents are intended to streamline the review of next generation sequencing-based tests. On July 8, the US Food and Drug Administration (FDA or Agency) issued two draft guidance documents...more

DMEC Conference Focuses on Leaves and Reasonable Accommodation

Last week, the Disability Management Employer Coalition held its annual conference in New Orleans. The conference focused on how employers can bring individuals with disabilities into the workplace and manage their needs once...more

Boosts in Ransomware Attacks Spark Multiple Government Agency Responses

Following a recent U.S. government interagency report indicating that, on average, there has been an alarming 300 percent spike in daily ransomware attacks since early 2016 as compared with 2015, the U.S. Department of Health...more

Unplanned EHR Disruptions–Common for Hospitals

The prevalence of ransomware attacks is increasing. In fact, “[o]n average, more than 4,000 ransomware attacks have occurred daily since January 1, 2016,” according to a recent interagency government report. Given this...more

University of Mississippi Medical Center settles HIPAA violations for $2.75M

The Office for Civil Rights (OCR) has obtained another big settlement from a covered entity resulting from a data breach. This most recent settlement of fines and penalties and a Resolution Agreement is with the University of...more

Another Jury Acquits in One of the First Few Prosecutions of Health Care Executives Following DOJ’s Yates Memo

Last month, we reported on a Massachusetts federal court jury’s decision to acquit the former CEO of Warner Chilcott in one of the first prosecutions of a health care executive following the Department of Justice’s (“DOJ”)...more

FDA’s new Next Generation Sequencing Draft Guidance leaves fundamental questions unanswered: key points

The Food and Drug Administration has released a 25-page Draft Guidance document addressing FDA oversight of certain applications of Next Generation Sequencing (NGS)-based technology. The Draft Guidance - "Use of Standards in...more

CMS Unveils New Mandatory Medicare Bundled Payment Models for Cardiac & Hip Fracture Cases, Plus Proposed Refinements to CJR...

On July 25, 2016, CMS announced ambitious, multi-pronged plans to expand mandatory Medicare coordinated care/bundled payment programs, promote the use of cardiac rehabilitation services, refine current Comprehensive Care for...more

Federal Circuit Holds Claims to Cell Freezing Methods to Be Patent-Eligible

On July 5, 2016, the Federal Circuit held that claims reciting methods for cryopreserving hepatocytes in U.S. Patent No. 7,604,929 ("the '929 patent") are eligible for patenting. The decision vacated a lower court's holding...more

CMS Hosts Call on Potential Future Changes to Open Payments/Sunshine Act Reporting Requirements (Aug. 2)

On August 2, 2016, CMS is hosting a Special Open Door Forum Call on potential future changes to Open Payments/Physician Payments Sunshine Act requirements for reporting payments and transfers of value made by drug and device...more

OCR Makes It Official: Ransomware Attacks Are HIPAA Breaches

Ransomware attacks appear to be increasing in frequency as well as severity. Ransomware is malicious software that encrypts data until a ransom is paid to the hacker. For healthcare providers, the inability to access...more

HHS Releases Guidance On Ransomware And HIPAA

On July 11, 2016, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) published new guidance on the how HIPAA applies to ransomware prevention and attacks. Specifically, the guidance lays out...more

HHS: Ransomware Attacks Can Trigger Reporting Requirements

On July 11, 2016, the HHS Office for Civil Rights (OCR) released new HIPAA guidance regarding ransomware. The Fact Sheet, issued by OCR on July 11, covers various issues relating to ransomware, including reporting...more

Cybersecurity News & Notes – July 2016 #4

In Case You Missed It: U.S. Major party platforms address cybersecurity. The two major parties have released their 2016 election platforms, both of which include cybersecurity planks. The Republican platform’s perspective...more

HHS OCR Guidance on Ransomware Attacks: They Constitute a “Security Incident” and Are Likely a Data Breach

On July 11, 2016, the HHS Office of Civil Rights (OCR) released guidance on HIPAA covered entities’ responsibilities in a ransomware attack, a type of cyber-attack that has targeted the health care sector extensively in...more

Pennsylvania Enacts Biosimilar Substitution Law

On July 20, Pennsylvania Governor Tom Wolf signed into law Senate Bill 514, which allows pharmacists to substitute for a brand name biological product a less expensive biosimilar product that has been deemed interchangeable...more

Alabama Department of Revenue Now Argues that ALL Software—Canned or Custom—Is Subject to Sales/Use Tax

The Alabama Tax Tribunal (the “Tribunal”) ruled in a recent case that the taxpayer-hospital was entitled to a refund of the sales tax paid on the purchase of software that had been customized for its particular functions...more

Report Warns Providers of HIPAA Violations When Responding to Negative Online Reviews

ProPublica, a public interest investigative newsroom, recently identified more than 3,500 one-star medical reviews on Yelp in which patients complained about privacy issues. ProPublica determined that “in dozens of instances,...more

Protected Health Information: Providers Must Proceed with Caution

Medical records are a powerful weapon in the courtroom. They may reveal the extent of an individual’s injury in a personal injury case or substantiate the severity of an individual’s mental illness when that mental illness is...more

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