Tag Archives: Health Privacy

California Legislature Advances Privacy Legislation

Today, the California Senate Judiciary Committee will consider AB 1281, which would extend the California Consumer Privacy Act’s (CCPA) business-to-business and employment exemptions until January 1, 2022, in the event that the pending ballot initiative—which also would extend the exemptions—does not pass this November. In addition, the Committee will consider two contact tracing measures, AB … Continue Reading

Bipartisan Bill Introduced in Senate Would Regulate COVID-19 Apps

Senators Maria Cantwell (D-WA) and Bill Cassidy (R-LA) introduced bipartisan legislation this week to address privacy issues in the COVID-19 era.  The proposal, entitled the “Exposure Notification Privacy Act,” would regulate “automated exposure notification services” developed to respond to COVID-19.  This bipartisan legislation comes on the heels of dueling privacy proposals from both political parties.  … Continue Reading

HHS Announces Enforcement Discretion Over the Implementation of Interoperability Final Rules Due to COVID-19 Public Health Emergency

In a new post on the Covington Digital Health blog, our colleagues discuss the Department of Health and Human Services (“HHS”) announcement of enforcement discretion to “permit compliance flexibilities” for the implementation of the interoperability final rules issued on March 9th, 2020.  The final rules are intended to improve patient access to electronic health information … Continue Reading

HHS Seeks to Facilitate Certain Uses and Disclosures of Health Data to Public Health and Health Oversight Agencies Amidst COVID-19 Nationwide Public Health Emergency

On April 2, 2020, the U.S. Department of Health and Human Services (“HHS”) issued a Notification of Enforcement Discretion (the “Notification”) regarding the disclosure of protected health information (“PHI”) to public health authorities and use of PHI to perform analytics for such authorities.  Designed to “facilitate uses and disclosures for public health and health oversight … Continue Reading

HHS Relaxes Enforcement of Certain HIPAA Provisions Amidst COVID-19 Nationwide Public Health Emergency

This month, the U.S. Department of Health and Human Services (“HHS”) issued guidance waiving enforcement of certain provisions of the Health Insurance Portability and Accountability Act (“HIPAA”) in response to the COVID-19 nationwide public health emergency.… Continue Reading

Legislation Seeks to Regulate Privacy and Security of Wearables and Genetic Testing Kits

Last week, Senators Amy Klobuchar (D-MN) and Lisa Murkowski (R-AK) introduced the Protecting Personal Health Data Act (S. 1842), which would provide new privacy and security rules from the Department of Health and Human Services (“HHS”) for technologies that collect personal health data, such as wearable fitness trackers, social-media sites focused on health data or … Continue Reading

HHS Extends Comment Period for Proposed Rules on Patient Access and Interoperability

On April 19, 2019, the Department of Health and Human Services (HHS) announced a 30-day extension, until June 3, 2019, to the comment period for two rules proposed by the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC). The CMS proposed rule aims to … Continue Reading

HHS Releases Voluntary Cybersecurity Guidance

Hospitals and other health care organizations are attractive targets for cyber-attacks, in part because their databases contain medical records and other sensitive information. Breaches of this information could have very serious implications for patients.  Moreover, electronics connected to a health care facility’s network keep people alive, distribute medicines, and monitor vital signs. As a result, … Continue Reading

The Implications of the GDPR on Clinical Trials in Europe

On October 23, 2018, the European Federation of Pharmaceutical Industries in cooperation with the Future of Privacy Forum and the Center for Information Policy Leadership will organize a workshop entitled, “Can GDPR Work for Health Research.”  In the first session, the workshop will discuss the implications of the General Data Protection Regulation (“GDPR”) on clinical … Continue Reading

Future of Privacy Forum: Privacy Papers for Policymakers 2018

On the heels of the Federal Trade Commission’s (“FTC”) third annual “PrivacyCon,” the Future of Privacy Forum hosted its eighth annual “Privacy Papers for Policymakers” event on Capitol Hill—a gathering in which academics present their original scholarly works on privacy-related topics to D.C. policy wonks who may have a hand in shaping laws and regulations … Continue Reading

Digital Health Checkup: Key Questions to Consider in the Digital Health Sector

Covington’s global cross-practice Digital Health team has posted an illuminating three-part series on the Covington Digital Health blog that covers key questions entities should be asking as they seek to fit together the regulatory and commercial pieces of the complex digital health puzzle. In the first part of the series, the Digital Health team answers key regulatory questions … Continue Reading

UK Government Proposes Cybersecurity Law with Serious Fines

Earlier this month, the UK Government published a consultation on plans to implement the EU Directive on security of network and information systems (the “NIS Directive”, otherwise known as the Cybersecurity Directive).  The consultation includes a proposal to fine firms that fail to implement “appropriate and proportionate security measures” up to EUR 20 million or … Continue Reading

Digital Health Check-Up: Key Questions Market Players Should Be Asking

On our sister blog, CovingtonDigitalHealth, our global cross-practice digital health team has launched a three-part series on the key questions the technology, life sciences and communications industries should be considering as they fit together the regulatory and commercial pieces of the complex digital health puzzle.  Read the first post in the series here.… Continue Reading

ICO Rules UK Hospital-DeepMind Trial Failed to Comply with UK Data Protection Law

The UK Information Commissioner’s Office (“ICO”), which enforces data protection legislation in the UK, has ruled that the NHS Royal Free Foundation Trust (“Royal Free”), which manages a London hospital, failed to comply with the UK Data Protection Act 1998 in providing 1.6 million patient records to Google DeepMind (“DeepMind”), requiring the Royal Free to … Continue Reading

European Cloud in Health Advisory Council Calls For Review of eHealth Rules and Ethics of Medical Data Re-Use

In a new post on the Covington Digital Health blog, our colleagues discuss a new European Cloud in Health Advisory Council whitepaper calling for a review of European healthcare data protection rules holding back greater adoption of cloud computing and AI; and for more discussion about the ethics and governance of re-use of patient data for research and planning.  To read … Continue Reading

Irish Data Protection Commissioner Releases 2016 Annual Report

By Denitsa Marinova On April 11, 2017, the Data Protection Commissioner of Ireland (DPC) published her annual report for 2016, highlighting key developments and activities for the past year and outlining priorities for 2017 and beyond.  The report will be of interest to Irish entities and multinational organizations with a base in Ireland, including companies … Continue Reading

EU Organizations Call for More Support for Cloud Computing in Healthcare

The EU-U.S. Privacy Shield’s recent introduction has created an efficient mechanism to ensure that trans-Atlantic personal data flows are lawful.  With that in place, attention is now turning back to restrictions within the EU, particularly around hosting data in cloud computing services. European healthcare is particularly affected by such restrictions.  This has motivated a significant … Continue Reading

UK Government Considering New Patient Data Security and Research Consent Standards, Sanctions

A new post on the Covington eHealth blog reports that the UK government is running a consultation around NHS patient data security standards and a new legal framework for secondary uses (e.g. research) of patient data.  To find out more about the proposals and the consultation, please click 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

EU Cyber Security Directive To Enter Into Force In August

The EU Network and Information Security (NIS) Directive now looks likely to enter into force in August of this year.  Member States will then have 21 months to implement it into national law before the new security and incident notification obligations will start to apply to the following entities: designated* “operators of essential services” within … 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

FTC Releases Agenda for First-Ever PrivacyCon

On Tuesday, the FTC announced the agenda for PrivacyCon, which is being billed as a “first-of-its-kind event” that will facilitate discussions between researchers and academics about privacy and security.  The FTC also released abstracts for the research that will be presented at the conference, scheduled for January 14.  PrivacyCon follows a call from the FTC … Continue Reading
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