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Cliff Notes from the Joint OCR/NIST HIPAA Security Conference

As a service to our readers, we have distilled last week’s joint HHS Office of Civil Rights (OCR) and National Institute of Standards in Technology (NIST) conference, “Safeguarding Health Information: Building Assurance...more

Blog: OCR Rep Discusses HIPAA Violations, Enforcement Actions, and Upcoming Audit Program

Last week, the National Institute of Standards and Technology (“NIST”), in conjunction with the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”), hosted a conference entitled “Safeguarding Health...more

Realizing the Potential of Telemedicine in China, Part 1: Protecting Your IP

This post is the second in Foley’s blogs on China telemedicine and the first in the blog series, “Realizing the Potential of Telemedicine in China,” meant to address top issues facing U.S. companies looking to enter the...more

A Brave New World of Transparency Reporting: CMS Launches Open Payments Website

September 30th marked the launch of transparency reports under the Sunshine Act through a new Open Payments website hosted by the Centers for Medicare & Medicaid Services (CMS)....more

Blog: CMS Releases First Year Open Payments Data

The Centers for Medicare & Medicaid Services (CMS) promised the government, industry and the public that it would release the first round of data in connection with the Physician Payment Sunshine Act by September 30, 2014,...more

Court Finds FDA Explanation of Knee Implant Reversal Lame

The FDA had approved the mesh—called the Collagen Scaffold—in December 2008. But after the change in administrations the following month, the agency decided that the approval process had been flawed and had been the focus of...more

The Pain Drain - The Continuing Impact of Pain Management on Health-Care Providers

Over a hundred million Americans suffer from chronic pain. To combat this epidemic, health-care providers have increasingly turned to opioid analgesics. As a result, opioid analgesic use has risen dramatically over the past...more

Judge Dismisses FDA Spying Case But Not Because It’s Innocent

Earlier this week a federal judge dismissed a lawsuit by six former and current FDA scientists who allege that the FDA retaliated and spied on them for blowing the whistle on FDA approval of medical devices that put cancer...more

“LoProCo”, 12,915 Complaints, and Other Lessons from OCR/NIST

12,915 complaints were reported in 2013 to the Department of Health and Human Services Office of Civil Rights (“OCR”) according to Illiana L. Peters, Senior Adviser for HIPAA Compliance and Enforcement. Cozen O’Connor...more

FDA Allowing Additional Comment Period for Draft Social Media Guidances

The Food and Drug Administration (FDA) is reopening the comment period for two draft social media guidances in response to requests for additional time to allow interested persons to submit comments. Beginning September 29,...more

Telemedicine and the Interstate Medical Licensure Compact is Here: Will it Succeed?

After more than 18 months in the works, and with much public coverage in the telemedicine industry, the Federation of State Medical Boards (FSMB) made its Interstate Medical Licensure Compact available for review by state...more

Telemedicine: What’s Next – 2014 Provider Survey

Telemedicine is a booming sector for health care, stemming from a strong desire to improve the overall quality of care and reach new patients in new markets both around the block and around the world. The benefits of...more

Outrageous Opinions in Registration Statements

In Omnicare, Inc. v. Laborers District Council Construction Industry Pension Fund, No. 13-435, the respondents fired back at the petitioners in a brief filed with the Supreme Court, posing a simple question: “Whether...more

“Access Denied” – Understand How Your Electronic Health Records Are Controlled

Earlier this week, my colleague Dianne Bourque commented on a small medical practice’s inability to access its patients’ medical records one July day after its EHR vendor blocked the practice from pulling the data stored in...more

OIG Warns About Risk of Drug Coupons, But Offers No Solution

On September 18, 2014, the OIG simultaneously issued a Report [PDF] and Special Advisory Bulletin [PDF] warning about the potential fraud and abuse risks posed by coupons offered by pharmaceutical manufacturers when those...more

Administration Moves to Address Antibiotic Resistance

On September 18, 2014, the Obama administration announced a comprehensive initiative to combat the growing threat of antibiotic-resistant bacteria. The initiative centers largely on preventing overuse of antibiotics and...more

Three Things Tech Titans Have That eHealth Needs

Large tech companies have been virtually lining up to announce their foray into the digital health space recently. Industry analysts have long suspected that an incumbent industry with a strong customer base could come in and...more

Scripts Newsletter - October 2014

In this issue: - Health Care Decisions — Who Decides? - Medical Software Licensing — Tips from the Trenches - An Ounce of Prevention — The Importance of Periodic Corporate Audits - ACA -...more

Medical Software Licensing - Tips from the Trenches

Medical offices are adopting complex software products such as electronic health record (EHR) systems and practice management systems in increasing numbers. While the ultimate hope is to improve patient care and practice...more

OIG Reports Medicare Part B Supplying and Dispensing Fees Significantly Higher Than Those Under Part D and Medicaid

According to a recently released report from the HHS OIG, pharmacies are reimbursed significantly more for dispensing drugs under Medicare Part B than they would be for dispensing the same drugs under Medicare Part D and...more

FDA Releases Draft Guidance Updating Agency Policies on the Informed Consent Process for Clinical Trials

On July 15, 2014, the U.S. Food and Drug Administration (“FDA”) released draft guidance that provides extensive commentary on FDA’s current thinking regarding the clinical trial informed consent process. Once finalized, this...more

Court Allows Counterclaim Against Whistleblower for Breach of Employment Agreement

A federal court in New Jersey has permitted a defendant in a False Claims case to defend itself on the grounds that the whistleblower/ex-employees breached their employment agreements by using and disclosing confidential...more

AMA Call for Electronic Health Record Systems Improvements

On September 16, the American Medical Association (AMA) released a new framework intended to improve the development and integration of Electronic Health Record (EHR) systems....more

OIG Issues Special Advisory Bulletin on Pharmaceutical Manufacturer Copayment Coupons

On September 19, 2014, the Department of Health and Human Services Office of Inspector General (“OIG”) issued a Special Advisory Bulletin on Pharmaceutical Manufacturer Coupons (the “Advisory Bulletin”) warning pharmaceutical...more

Health Update - September 2014

Engaging Patients While Addressing Their Privacy Concerns: The Experience of Project HealthDesign - Patients are using the Internet, personal health records (PHRs) and mobile applications or “apps” to collect and...more

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