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
In February 2021, the European Commission (“Commission”) released a report on European Union (“EU”) Member States’ laws governing the processing of health data. The report discusses three general types of health data uses: primary use for health care services; secondary use for public health purposes; and secondary use for scientific research purposes. For each of … Continue Reading
On February 2, 2021, the European Data Protection Board (“Board”) responded to questions submitted by the European Commission (“Commission”) on the application of the General Data Protection Regulation (“GDPR”) to health research. The Board also announced that it is currently working on guidelines on the processing of personal data for scientific research purposes, which it … Continue Reading
In a new post on the Covington Digital Health blog, our colleagues discuss a recent settlement between the Federal Trade Commission (“FTC”) and Flo Health, Inc. (“Flo”), the developer of a popular menstrual cycle and fertility-tracking application. The settlement resolves allegations that Flo shared app users’ health information with outside third parties after promising that … Continue Reading
In a new post of the Covington Digital Health blog, our colleagues discuss the proposed rule issued by the Office for Civil Rights of the U.S. Department of Health and Human Services to modify the Privacy Rule promulgated under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and the Health Information Technology for … 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
On 3 July 2020, the German parliament passed a draft bill (German language) for patient data protection and for more digitalisation in the German healthcare system (Patientendaten-Schutz-Gesetz). The draft bill is currently in the legislative procedure and is expected to enter into force in autumn 2020. One of the main objectives of the bill is … 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
House and Senate Democrats recently unveiled proposed legislation—tentatively titled the “Public Health Emergency Privacy Act”—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. Below we describe the proposed Public Health Emergency Privacy Act and how it differs with a separate … Continue Reading
On May 8, 2020, the Federal Trade Commission (“FTC”) issued a notice soliciting public comment regarding whether changes should be made to its Health Breach Notification Rule (the “Rule”). The request for comment is part of a periodic review process “to ensure that [FTC rules] are keeping pace with changes in the economy, technology, and … Continue Reading
On April 21, 2020, the Regulation on the Requirements and Reimbursement Process for Digital Health Applications (Digitale Gesundheitsanwendungen-Verordnung or „DiGAV“, available here) entered into force in Germany. Among other provisions, the DiGAV includes specific IT security and privacy requirements. Shortly after the law took effect, Germany’s Federal Medicines and Medical Devices Agency (“BfArM”) also released … 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
As we anticipated in a previous blog post, on April 22, 2020, the European Data Protection Board (“EDPB”) issued new guidelines on the use of location data and contact tracing apps in the context of the present COVID-19 pandemic. The EDPB’s new guidelines complement and build on similar guidance previously issued by the Board itself … Continue Reading
On April 17, 2020, the UK’s Information Commissioner’s Office (“ICO”) issued an opinion on the recently announced Apple-Google initiative to develop a Bluetooth-based Contact Tracing Framework (“CTF”) to help prevent the spread of COVID-19. The ICO opinion is generally supportive of the Apple-Google proposal and perceives it to be, at this early phase, aligned with … Continue Reading
On 8 April 2020, the European Commission adopted a recommendation on a common European Union toolbox for the use of technology and data to address the COVID-19 crisis (“Recommendation”). The Recommendation responds to calls for a common EU approach to the use of mobile apps in combatting COVID-19—one that improves the efficacy of the technology … Continue Reading
On March 28, 2020, the “Federal Act for the Protection of the Population against an Epidemic of National Significance” (Bevölkerungsschutzgesetz) went into effect. The law forms part of an emergency legislative package introduced by the German government in response to COVID-19. The law amends the Social Code V (SGB V) by introducing a new provision … 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
On 18 March, 2020, the Hellenic (Greek) Data Protection Authority (“HDPA”) issued guidelines on data protection and COVID-19. With these guidelines, the HDPA aims to provide guidance on the interpretation and application of data protection legislation during the COVID-19 pandemic. In this blog, we summarise the key points included in the HDPA’s guidelines. Categorization of … 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
On March 17, 2020, the Executive Committee of the Global Privacy Assembly (“GPA”) issued a statement on data protection in the context of the COVID-19 pandemic. The GPA is an entity representing data protection and privacy regulators around the globe, formerly known as the International Conference of Data Protection and Privacy Commissioners (“ICDPPC”). The GPA … Continue Reading
