Health Science, Computers & Technology

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Changing Time for Clinical Laboratories

As Bob Dylan wrote, ‘‘The times, they are a-changin’ ’’ While Dylan certainly had larger issues in mind than the state of the clinical laboratory industry, it still is a fair description of what is happening for laboratories...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On April 21, 2016, CMS issued a proposed rule entitled, “Medicare Program: FY 2017 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements.” This...more

New HIPAA Phase 2 Audits: Targets Notified by Email Only

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) recently announced the long-awaited launch of Phase 2 of its HIPAA Audit Program (Phase 2 Audits). The Phase 2 Audits will review the policies...more

New ACA, et. al. FAQs Cover Items From “Top” to “Bottom”

On April 20, the “Big Three” agencies (DOL, Treasury/IRS, and HHS) released another set of FAQs (the 31st, for those of you counting at home). Consistent with earlier FAQs, the new FAQs cover a broad range of items under the...more

Wyoming Medical Center victim of phishing scheme affecting 3,184 patients

Phishing incidents in February that may have compromised the data of 3,184 patients, including their names, dates of birth, medical record and account numbers, dates of service and medical information is causing Wyoming...more

FDA Extends Comment Period on Third-Party Medical Device Servicing

As an update to my post on Friday, April 22, FDA has extended the deadline for comments on third-party servicing of medical devices. According to FDA’s notice of extension, comments are now due by June 3, 2016....more

Health Update - April 2016 #2

How to Prepare for "Phase Two" HIPAA Compliance Audits: Tips on Getting Ready for Scrutiny - Editor's Note: Now that the Department of Health and Human Services (HHS) has announced that it is beginning the next round of...more

Spring Showers Bring HIPAA Breaches

OCR has announced several recent settlement agreements to resolve violations of the Health Insurance Portability and Accountability Act (“HIPAA”). These settlement amounts range from $25,000 to $3.9 million dollars and...more

OCR Releases Updated HIPAA Audit Protocol and Business Associate Listing Template

The Office of Civil Rights (OCR) recently updated the audit protocol that it will be using to assess Covered Entities’ and Business Associate’s compliance with the Health Insurance Portability and Accountability Act (HIPAA)...more

HHS Reopens Comment Period for Proposed Rule on 340B Drug Program

The U.S. Department of Health and Human Services (HHS) is reopening the comment period for the proposed rule titled “340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation.” HHS released...more

Wave of the Future: Government Releases New Tool to Aid Medical App Developers Comply with HIPAA

This month, the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), the Office of the National Coordinator for Health Information Technology (ONC), and the Federal Trade Commission (FTC)...more

Department of Health and Human Services Cracks Down on Vendor Oversight in Recent Hospital Settlements

From the rise in ransomware attacks to inadvertent disclosure of information by subcontractors, the health services industry is reminded that a potential consequence of a data breach is the threat of a regulatory enforcement...more

Veterans Affairs to Permit Acquisition of Non-TAA-Compliant Drugs

In a significant policy reversal, the Department of Veterans Affairs (VA) has announced that it will require all covered drugs under the Veterans Health Care Act (VHCA) to be offered on Federal Supply Schedule (FSS)...more

Court Report - April 2016 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Teva Pharmaceuticals USA Inc. et al. v. Biocon Ltd. et al. 1:16-cv-00278; filed April 19, 2015 in the District Court of...more

Keeping Coverage Online: Fourth Circuit Confirms Internet Data Breach Claim Triggers Commercial General Liability Policies

In a clear rejection of insurers’ attempts to artificially narrow the broad coverage provided by commercial general liability (“CGL”) policies, the United States Court of Appeals for the Fourth Circuit recently held that an...more

Health Care E-Note - April 2016

Patient care is not confined to a single office or exam room, or a single physician or other provider. Caring for patients these days now includes complex coordination among physicians, nurses, technicians, staff, management,...more

FTC Releases "Cheat Sheet" for Developing a Secure Mobile Health Application

The Federal Trade Commission (FTC), in partnership with other federal agencies, has released an online tool that provides developers legal guidance for the creation of mobile health applications (apps). Companies that are...more

FDA Still Seeking Manufacturer Views on Medical Device ISO Regulation

On March 4, 2016, the FDA issued notice in the Federal Register that it had opened a docket to accept comments on the agency’s proposed plan to address the refurbishing, remarketing, rebuilding, remanufacturing, and servicing...more

Mobile App Compliance for Dummies: New Tool Helps Developers Understand Their Legal Compliance Requirements

In a joint effort by the Federal Trade Commission (FTC), Office for Civil Rights (OCR), HHS Office of National Coordinator for Health Information Technology (ONC), and Food and Drug Administration (FDA), a new web-based tool...more

Epic Verdict in Trade Secrets Case

Last week, a federal jury in Wisconsin awarded almost $1 billion to Epic Systems Corporation in its trade secrets case against Indian consulting company Tata Consulting Services, Ltd., and its American unit, Tata America...more

AGG Food and Drug Newsletter - April 2016

Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more

Health Law Insights Newsletter - Issue 8 - April 2016

McCarter & English, LLP’s Health Care Group presents Issue 8 of the Health Law Insights, which discusses the latest legal issues in the health care industry. NATIONAL - New Payment Model for Part B Drugs Proposed -...more

Not a Check-the-Box Exercise: Failure to Have Signed BAA Results in Substantial Fine

A group practice that was the victim of a silver-harvesting scam has agreed to pay the U.S. Department of Health and Human Services (“HHS”) $750,000 to settle charges that it released protected health information (“PHI”) of...more

New report warns health care industry to expect more ransomware attacks

A new report of a survey of around 30 mid-sized hospitals by the Health Information Trust Alliance (HITRUST) concludes that health care entities should be prepared for an increase in ransomware attacks in the near future....more

OCR issues audit protocol and targets over 800 entities—business associates too

The Office for Civil Rights (OCR) has issued its revamped audit protocol for its second phase of auditing covered entities and business associates’ compliance with the HIPAA Privacy, Security and Breach Notification Rules....more

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