On March 18, 2024, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) updated its guidance on the use of online tracking technology by covered entities regulated by the Health...more
3/26/2024
/ Business Associates ,
Covered Entities ,
Cybersecurity ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
OCR ,
PHI ,
Popular
On April 27, 2023, Washington State Governor Jay Inslee signed a far-reaching health privacy law entitled the “My Health My Data Act” (the Act), which extends protections to consumer health data collected by entities not...more
On June 24, 2022, the United States Supreme Court issued its decision in Dobbs v. Jackson Women's Health Organization,1 opening a legal path to state laws restricting or prohibiting access to certain reproductive health...more
7/22/2022
/ Abortion ,
Biden Administration ,
Data Collection ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Dobbs v. Jackson Women’s Health Organization ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
Pregnancy ,
Privacy Concerns ,
SCOTUS
In this issue, we discuss U.S. Food and Drug Administration (FDA) regulation of wellness devices. We also look at good commercial contracting hygiene for digital health start-ups. Other articles include recent enforcement...more
In this issue, we discuss how real-world evidence can be an important component of satisfying drug approval and post-approval study requirements and also, can provide other tangible advantages to drug sponsors. We also look...more
10/22/2020
/ Bayh-Dole Act ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Drug Approvals ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Real World Evidence ,
Telehealth
The COVID-19 emergency presents an unprecedented need to communicate quickly and effectively from a distance. Telehealth and telecommunications applications more broadly are poised to address the potentially crushing demand...more
Beware of “Most Favored Nations” Clauses in Commercial Contracts -
Imagine that your digital health company has developed a groundbreaking product. You are eager to monetize the product, so you sign non-disclosure...more
11/20/2019
/ Antitrust Violations ,
Competition ,
Contract Negotiations ,
Cybersecurity ,
Digital Health ,
Electronic Protected Health Information (ePHI) ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospitals ,
Medical Devices ,
Most-Favored Nations ,
Patient Privacy Rights ,
PHI ,
Preferred Hospital Networks Arrangement
Avoid Potential Pitfalls When Incorporating Third-Party Software into Wearable Products -
The global market for wearable devices continues to expand rapidly. Digital health companies that manufacture and sell their own...more
6/24/2019
/ Digital Health ,
Electronic Protected Health Information (ePHI) ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Health Technology ,
HIPAA Privacy Rule ,
Life Sciences ,
Medical Devices ,
Medical Software ,
Pharmaceutical Industry ,
Popular ,
Pre-Market Notification ,
Regulatory Oversight ,
Regulatory Standards
Evaluating Prospective Partners When Scaling Your Digital Health Company (Part 2) -
In Part 1 of this article from our last Digital Health Report, we looked at the opportunities and some of the potential limitations of...more
10/31/2018
/ Business Model ,
Digital Health ,
Early Stage Companies ,
Entrepreneurs ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Partnerships ,
Patent-Eligible Subject Matter ,
Patents ,
Startups ,
Strategic Planning ,
Technology Sector