July 7, 2016, Health Privacy – Inside Privacy

Last month, the FDA released a draft guidance document on the sharing of patient-specific data associated with medical devices, including information recorded, stored, processed, retrieved, and/or derived from the device.  A new post on Covington’s Inside Medical Devices blog discusses the draft guidance and its implications for sharing patient information.… ...

July 7, 2016, Health Privacy – Inside Privacy

A new post over on Covington’s eHealth blog discusses a recent enforcement action taken by the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) against Catholic Health Care Services, a business associate under HIPAA, arising out of a stolen iPhone.  This recent enforcement action should put business associates … Continue ...

July 7, 2016, HIPAA and Data Privacy – Covington eHealth

The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) recently announced a significant settlement with Catholic Health Care Services of the Archdiocese of Philadelphia (CHCS), a business associate under HIPAA, arising from a breach of protected health information (PHI) after the theft of an employee’s iPhone.  The iPhone … ...

July 5, 2016, FDA Device Regulation – Inside Medical Devices

Last month, the FDA released a draft guidance document on the sharing of patient-specific data associated with medical devices, including information recorded, stored, processed, retrieved, and/or derived from the device.  FDA noted that patients increasingly seek to play an active role in their own health care and that providing patients access to information ...

April 28, 2016, Health Privacy – Inside Privacy

The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services has been busy.  In addition to its recent efforts to begin audits of covered entities and business associates, OCR has announced a slew of enforcement actions against covered entities for alleged HIPAA violations. Last month, OCR announced two seven-figure settlements … ...

April 21, 2016, Health Privacy – Inside Privacy

The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) has begun to audit covered entities and business associates for compliance with HIPAA.   A new post on the Covington eHealth blog discusses recent developments in OCR’s efforts  to move these audits forward.… Continue Reading

April 21, 2016, HIPAA and Data Privacy – Covington eHealth

Phase 2 HIPAA Audits Underway The HHS Office for Civil Rights (OCR) has begun its effort to audit covered entities and business associates for compliance with HIPAA. We have previously reported on OCR’s preparations for these proactive audits. OCR implemented Phase 1 of the program in 2011 as a pilot program, under which OCR evaluated … Continue Reading

April 11, 2016, Dena Feldman – Inside Privacy

A new post on the Covington eHealth blog discusses the new web-based interactive tool released by the FTC, in conjunction with HHS and the FDA, to assist mobile health app developers in navigating applicable federal laws and regulations in the areas of advertising and marketing, medical devices, and data security and privacy.  As part of … Continue Reading

April 7, 2016, Christina Kuhn – Inside Medical Devices

A new post on the Covington eHealth blog discusses the new web-based interactive tool released by the FTC to assist mobile health app developers in navigating applicable federal laws and regulations in the areas of advertising and marketing, medical devices, and data security and privacy.… Continue Reading

April 7, 2016, HIPAA and Data Privacy – Covington eHealth

On April 5, the Federal Trade Commission (FTC), in conjunction with the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS), released a new web-based interactive tool to assist mobile health app developers in navigating applicable federal laws and regulations in the areas of advertising and marketing, medical devices, and … ...

April 1, 2016, HIPAA and Data Privacy – Covington eHealth

On February 29, 2016, the Centers for Medicare and Medicaid Services (CMS) issued a State Medicaid Directors Letter (SMDL) that expands the scope of expenditures eligible for the 90 percent federal match for activities to promote the use of a health information exchange (HIE) and the adoption of certified electronic health record (EHR) technology by … Continue ...

February 26, 2016, Dena Feldman – Inside Privacy

On Tuesday, February 9, the Substance Abuse and Mental Health Services Administration (SAMHSA) published a proposed rule to update regulations at 42 C.F.R. Part 2 that protect the confidentiality of alcohol and drug abuse patient records.  The regulations were originally promulgated in 1975 and last substantively updated in 1987.  SAMHSA intends for these ...

January 28, 2016, Dena Feldman – Inside Privacy

The Senate Judiciary Committee today successfully reported H.R. 1428, the Judicial Redress Act of 2015.  However, the bill included an amendment to the House-passed version that has the potential to influence current negotiations between the United States and the European Union to reach a new Safe Harbor agreement. As we previously reported, the Judicial Redress ...

January 12, 2016, Dena Feldman – Inside Privacy

On January 6, as part of President Obama’s executive action to combat gun violence, HHS promulgated a final regulation modifying the HIPAA Privacy Rule to allow certain HIPAA covered entities to disclose limited information to the National Instant Criminal Background Check System (NICS).  We previously discussed the proposed rule here. Background:  The NICS, ...

January 6, 2016, Dena Feldman – Covington eHealth

Last week, the Centers for Medicare and Medicaid Services (CMS) published a request for information (RFI) seeking public comment regarding areas of certification and testing of health IT as part of the Electronic Health Records (EHR) meaningful use program. Beginning in 2018, participants in the Stage 3 Meaningful Use EHR incentive program must electronically ...

November 19, 2015, HIPAA and Data Privacy – Covington eHealth

While Americans continue the trend towards replacing the traditional phone call with email and texts, health care providers have yet to catch on when interacting with their patients. A recent survey by Nielsen Strategic Health Perspectives found that less than a third of Americans have access to digital communications with their physicians: The survey found … ...

October 13, 2015, Dena Feldman – Inside Privacy

A new post on Covington’s Inside Medical Devices blog discusses a new portal recently launched by HHS seeking questions from mobile health application developers.  The platform allows for individuals to both submit and review questions on the HIPAA implications of these mobile health applications.  To read the post, click here.… Continue Reading

October 12, 2015, Dena Feldman – Covington eHealth

A new post on Covington’s Inside Medical Devices blog discusses a new portal recently launched by HHS seeking questions from mobile health application developers.  The platform allows for individuals to both submit and review questions on the HIPAA implications of these mobile health applications.  To read the post, click here.… Continue Reading

October 9, 2015, Dena Feldman – Inside Medical Devices

On October 5, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services launched a new platform to enable developers of mobile health technology, as well as others “interested in the intersection of health information technology and HIPAA privacy protection.” OCR notes that there is currently “an explosion of technology … Continue ...

September 18, 2015, Dena Feldman – Covington eHealth

Recent news reports indicate that the Office for Civil Rights (OCR) at the Department of Health and Human Services (HHS) is planning to move ahead with its plan to begin proactive HIPAA audits of business associates and covered entities. In the past, OCR has relied primarily on self-reports of breaches from covered entities (as required … Continue Reading

July 15, 2015, Dena Feldman – Covington eHealth

A recent HIPAA enforcement action highlights the risk of health care providers using unsecured applications to store and share patient data. HHS reached a $218,499 settlement with St. Elizabeth’s Medical Center in Brighton, Massachusetts, a tertiary care hospital that offers both inpatient and outpatient services. The enforcement action followed allegations made ...

June 3, 2015, Dena Feldman – Covington eHealth

We recently posted on the Inside Privacy blog about an update to the Guide to Privacy and Security of Electronic Protected Health Information issued by the Office of the National Coordinator for Health Information (ONC).  The updated guide incorporates the most current standards in accordance with the new final rules, issued in 2013, under the Health Information ...

June 1, 2015, Dena Feldman – Inside Privacy

The  Office of the National Coordinator for Health Information (ONC) recently released an updated Guide to Privacy and Security of Electronic Health Information.  The guide aims to help individuals, providers, and the health IT community understand the role of HIPAA for interoperability of health information. This guide updates the previous version issued by the ...

November 18, 2014, Health Issues – Global Policy Watch

The mid-term election brings an historic changing of the guard in the health care leadership in Congress.  Republicans will take control of the Senate in January and gain key chairmanships.  Senior Democrats like Senators Harkin and Rockefeller, and Representatives Dingell and Waxman, who have been leaders on health policy issues for decades, are retiring. ...

May 27, 2014, Dena Feldman – Inside Medical Devices

The medical device tax is back in the news, after recent congressional efforts to delay or repeal the tax.  The most recent efforts arose in the context of the “tax extenders” bill, which extends until the end of 2015 more than 50 tax provisions that are due to expire at the end of 2014. In … Continue Reading

May 1, 2014, Dena Feldman – Inside Compensation

Recently, HHS Office of Civil Rights (OCR) announced that it has entered into settlement agreements with two entities following enforcement actions, both arising from stolen laptops that were not encrypted in accordance with the Security Rule. According to HHS, an unencrypted laptop was stolen from a physical therapy center in Springfield, Missouri.  The center ...

March 21, 2014, Dena Feldman – Inside Medical Devices

A recent analyst report indicates that health care organizations and internet-connected medical devices are increasingly vulnerable to cyber-attacks. The Health Care Cyberthreat Report was issued in February 2014 by the SANS Institute, which describes itself as a cooperative research and education organization that is a source of cybersecurity training, security ...

December 9, 2013, Dena Feldman – Inside Medical Devices

Recently, the Office of Inspector General (OIG) at HHS released a report on the HIPAA enforcement efforts of HHS’s Office for Civil Rights (OCR).  Specifically, the OIG looked at whether OCR’s efforts to enforce HIPAA’s Security Rule were adequate.  The OIG’s findings may lead to increased enforcement efforts by OCR. Background on the Security Rule … Continue ...

November 8, 2013, Dena Feldman – Inside Medical Devices

We have previously discussed the effect of sequestration on FDA user fees.  Pharmaceutical and device manufacturers pay these user fees into a fund, which the FDA then draws upon to accelerate approval of new products and devices.  However, despite the fact that these funds are paid by private industry and are not derived from general … Continue Reading

11/07/2013

WASHINGTON, DC, November 7, 2013 — Salix Pharmaceuticals, Ltd., and Santarus, Inc. announced today that the companies have entered into a merger agreement where Salix will acquire all of the outstanding stock of Santarus for $32 in cash per share, for a total value of approximately $2.6 billion. Covington & Burling LLP is advising Salix on both the acquisition ...

October 18, 2013, Dena Feldman – Inside Medical Devices

We previously reported about the prominent role played by the medical device tax in the government shutdown/debt ceiling negotiations.   At various points, repeal of the medical device tax was included in proposed measures to fund the government.  When full repeal appeared to be off the table, several sources reported that Congress had considered a two-year … ...

October 4, 2013, Dena Feldman – Inside Medical Devices

The medical device tax has played a prominent role in negotiations over the continued government shutdown.  We have previously discussed legislative efforts to repeal the medical device tax here and here. Just after midnight on Sunday, September 29, two days before appropriations were scheduled to lapse, the House of Representatives passed a continuing ...

August 12, 2013, Dena Feldman – Inside Medical Devices

Under the Budget Control Act, popularly known as the sequester, mandatory spending cuts are in effect at agencies across the federal government.  The Act was enacted as part of negotiated compromise in the summer of 2011 to secure an increase in the federal debt ceiling.  As part of the debt limit increase, Congress established the … Continue Reading

February 7, 2013, Covington Advisory

June 29, 2012, Covington Advisory

September 5, 2011, BNA Product Safety & Liability Reporter