Dena Feldman

Dena Feldman

Dena Feldman practices in the areas of health care, federal-state programs, and public policy and government affairs. Ms. Feldman advises clients on the federal rules and policies governing Medicare and Medicaid, including the new mandates of the Affordable Care Act. She has particular expertise regarding Medicare and Medicaid reimbursement for behavioral health services, including rules governing Medicare conditions of participation, institutions for mental diseases (IMDs), and treatment of forensic patients. Ms. Feldman also advises clients on health privacy issues arising under HIPAA, the HITECH Act, and state medical privacy laws.

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HHS Announces More HIPAA Enforcement Actions

The beginning of 2017 has brought a number of HIPAA enforcement actions involving covered entities. These enforcement actions indicate that HHS is continuing recent efforts to step up HIPAA enforcement and levy significant penalties for non-compliance. In January, HHS announced that it had reached a $475,000 settlement with a large health care network for failure … Continue Reading

Twenty-First Century Cures Act Includes HIPAA Provisions

A new post over on Covington’s eHealth blog discusses HIPAA-related provisions in the Twenty-First Century Cures Act, signed by President Obama on December 13.   These provisions direct HHS to consider HIPAA’s effects on mental health treatment and the availability of health data for research purposes.  Read the full post here.… Continue Reading

FDA Releases Draft Guidance on Dissemination of Patient-Specific Information by Device Manufacturers

Last month, the FDA released a draft guidance document on the sharing of patient-specific data associated with medical devices, including information recorded, stored, processed, retrieved, and/or derived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  A new post on Covington’s Inside Medical Devices blog discusses the draft guidance and its implications for sharing patient information.… Continue Reading

Significant HIPAA Fine Follows Business Associate’s Stolen iPhone

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 Reading

OCR Steps Up HIPAA Enforcement Following Breaches of Protected Health Information

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.… Continue Reading

FTC Releases Online Tool to Help Health App Developers Identify Applicable Laws

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

SAMHSA Proposes Changes to Confidentiality Rules

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 updates to … Continue Reading

Senate Committee Passes Judicial Redress Act, May Assist Safe Harbor Negotiations

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 … Continue Reading

HHS Issues Final Rule on HIPAA and Firearm Background Check Reporting

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, maintained by … Continue Reading

HHS Launches Portal Seeking Questions from Mobile Health Application Developers

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

HHS Updates Health Data Privacy and Security Guide

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 ONC … Continue Reading

Two HIPAA Settlements Follow Stolen Laptops

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 was … Continue Reading

HHS Releases New Tool to Assist with HIPAA Risk Assessments

On March 28, HHS released new resources on risk analysis requirements under the HIPAA Security Rule.  The HIPAA Security Rule governs how electronic individually identifiable health information is maintained by covered entities and business associates.  In short, it requires covered entities and business associates to implement certain physical, administrative, and technical safeguards to protect the … Continue Reading

WEDI Issues Guidance for Assessment of Potential Breaches under HIPAA

Recently, the Workgroup for Electronic Data Interchange (WEDI) published a Breach Risk Assessment Issue Brief for stakeholders to use in analyzing whether a breach of  protected health information (PHI) has occurred under the Health Insurance Portability and Accountability Act (HIPAA).  Background Under HIPAA’s breach notification rule, covered entities and business associates are required to notify … Continue Reading

HHS OIG Releases Report on HIPAA Enforcement Efforts

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 Reading

HITECH Update # 7: New HIPAA Requirements for Business Associates and Their Subcontractors

This post is part of our series on key aspects of the final HITECH omnibus rule published by the U.S. Department of Health and Human Services (HHS) in the Federal Register on January 25, 2013. Previous posts are available here. The regulations are effective March 26, 2013, but covered entities and business associates have until … Continue Reading

Minnesota AG Files First HIPAA Enforcement Action Against Business Associate

Last month, the Minnesota Attorney General filed a lawsuit in federal court against Accretive Health, Inc. alleging that the company violated various provisions of HIPAA as well as Minnesota consumer privacy and protection law.  Although HIPAA-covered entities have been the subject of enforcement actions by state AGs and the Department of Health and Human Services, … Continue Reading
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