Two recent actions by lawmakers are intended to address certain uses of technology in health. First, two Senators have introduced a bipartisan bill related to the collection and use of identifiable health data from wearable health trackers. Second, following an appeal from Democratic lawmakers, the Agency for Healthcare Research and Quality (“AHRQ”) plans to review … Continue Reading
It’s the stuff of science fiction: adversaries extract DNA information from a cup of coffee or postage stamp and use it infer one’s most private traits. However, a recently released study entitled, “Data Sanitization to Reduce Private Information Leakage from Functional Genomics” discusses how this can be achieved, along with privacy measures that the life … Continue Reading
In a new post on the Covington Digital Health blog, our colleagues discuss California Attorney General Xavier Becerra’s recent settlement against Glow, Inc., resolving allegations that the fertility app had “expose[d] millions of women’s personal and medical information.” The post explains the allegations and settlement terms, as well as takeaways for providers of digital health … Continue Reading
On September 1, the California legislature passed AB 713, a bill that creates a new healthcare-related exemption under the California Consumer Privacy Act of 2018 (“CCPA”). All provisions of the bill will take effect immediately to prevent the CCPA from “negatively impact[ing] certain health-related information and research,” except for the required contractual provisions described below. … Continue Reading
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
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
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
Senate Commerce Committee Chairman Roger Wicker is working on draft legislation that would regulate the collection and use of health and location information in connection with efforts to track and limit the spread of COVID-19. Some key highlights of the tentatively titled “COVID-19 Consumer Data Protection Act” include:… Continue Reading
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
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
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
On April 30, 2019, the Department of Health and Human Services (HHS) published in the Federal Register a notification of enforcement discretion indicating that it will lower the annual Civil Money Penalty (CMP) limits for three of the four penalty tiers in the Health Information Technology for Economic and Clinical Health Act (HITECH Act). The … Continue Reading
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
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
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
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
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
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
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
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
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
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
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
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
