Category

Health Privacy

06 May 2022

Digital Health Industry Take Note: New HIPAA Comment Opportunity and Guidance Addresses Growing Risk of Cybersecurity Attacks

Digital health companies should take note of new data privacy and security developments under the Health Insurance Portability and Accountability Act (HIPAA) that can affect product planning and customer negotiations.

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) has released a request for information (RFI) … Read More

EmailShare
27 April 2022

EU Data Governance Act – Edging Closer to a European Single Market for Data

On 6 April 2022, the European Parliament formally approved the Data Governance Act (“DGA”), which establishes a legal framework to promote the availability of data and increase trust in data sharing across sectors in the EU. Some of the key objectives of the new legislation include enabling the re-use of … Read More

EmailShare
28 March 2022

Developments in Health Privacy and Cybersecurity Policy and Regulation: OCR Issues Cybersecurity Warnings and New Health Data Legislation Is Introduced

On March 17, 2022, the U.S. Department of Health and Human Service’s Office for Civil Rights (“OCR”) issued industry guidance for Health Insurance Portability and Accountability Act (“HIPAA”) regulated entities to take preventative steps to protect against some of the more common, and often successful, cyber-attack techniques. For example, the … Read More

EmailShare
27 October 2021

How Artificial Intelligence Manufacturers Can Protect Themselves Against Future Negligence Claims

Innovative medical devices have changed the healthcare landscape and will continue making dramatic improvements in patient care. Nevertheless, the growth of such devices will inevitably lead to increased litigation over their alleged failures. All companies developing healthcare tech therefore need to consider measures to protect themselves against potential claims.

EmailShare
Read More
EmailShare
28 September 2021

Federal Trade Commission Hosts Panels Related to Consumer Privacy and Data Security at PrivacyCon

This summer, the Federal Trade Commission (“FTC”) hosted its sixth annual PrivacyCon, an event focused on the latest research and trends related to consumer privacy and data security. This years’ event was divided into six panels: Algorithms; Privacy Considerations and Understandings; Adtech; Internet of Things; Privacy-Children and Teens; and, … Read More

EmailShare
22 September 2021

Digital Health in the UK: MHRA Bold New (Regulatory) World?

In his statement to the House of Lords on September 16, Lord Frost announced that “we will use the provisions of the Medicines and Medical Devices Act 2021 to overhaul our clinical trial frameworks, based on outdated EU legislation, giving a major boost to the UK’s world-class R&D sector and … Read More

EmailShare
09 June 2021

NHS’ Plans to Share Patient Records with Third Parties

NHS Digital (the national custodian for health and care data in England) in May 2021, announced a new data sharing initiative called the General Practice Data for Planning and Research (GPDPR) service. The launch of the GPDPR could result in the historical medical records of up to 55 million patients … Read More

EmailShare
03 May 2021

Part II – Digital Health Passports in Europe: Amended Proposal for a Digital Green Certificate and Eligible Testing Methods

In March 2021, the European Commission released a proposal for the creation of a “Digital Green Certificate,” which will allow EU citizens to travel easier throughout the EU during the COVID-19 pandemic. Last week, the EU Member States agreed on some proposed changes to the proposal, including strengthening of the … Read More

EmailShare
07 April 2021

Part I – Digital Health Passports in Europe: Facilitating a Return to the “New Normal” or an Intrusion of Privacy?

With the roll-out of the COVID-19 vaccine and the start of easing of social distancing measures, the latest initiative being considered at a national as well as an international level is the introduction of so-called “digital health passports” or “immunity passports,” i.e., a tool to record and share the immune … Read More

EmailShare
1 2 3 8
XSLT Plugin by BMI Calculator