The U.S. Department of Health and Human Services Office for Civil Rights (HHS-OCR) has announced proposed modifications to the Health Insurance Portability and Accountability Act (HIPAA) Security Rule (the Proposed Rule). The...more
Wilson Sonsini’s 31st Annual Medical Device & Digital Health Conference will address topics of critical importance to medical device and digital health companies, including early and late-stage venture financing, partnering...more
5/15/2024
/ Acquisitions ,
Artificial Intelligence ,
Best Practices ,
Business Strategies ,
Business Valuations ,
Compensation ,
Data Privacy ,
Digital Health ,
Early Stage Companies ,
Events ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Technology ,
Innovation ,
Investment Management ,
Investment Opportunities ,
Investment Portfolios ,
Investors ,
Life Sciences ,
Med Tech ,
Medical Devices ,
Mergers ,
Reimbursements ,
Startups ,
Strategic Partnerships ,
Venture Capital
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 July 20, 2023, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) and the Federal Trade Commission (FTC) sent a joint letter to approximately 130 hospitals, telehealth providers, health...more
8/1/2023
/ Cybersecurity ,
Data Collection ,
Data Privacy ,
Data Security ,
Department of Health and Human Services (HHS) ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Healthcare Facilities ,
Mobile Apps ,
Personally Identifiable Information ,
Telehealth
On June 16, 2023, the Federal Trade Commission (FTC) announced a proposed settlement agreement (in the form of a stipulated order) with genetic testing company Vitagene, Inc., now known as 1Health.io (1Health.io), for...more
On May 17, 2023, the Federal Trade Commission (FTC) announced a proposed settlement agreement (in the form of a stipulated order) with Easy Healthcare Corporation, which operates the Premom fertility tracking app (Premom)....more
Wilson Sonsini’s 30th Annual Medical Device Digital Health Conference will address topics of critical importance to medical device and digital health companies today, including key healthcare regulatory considerations, the...more
5/24/2023
/ Acquisitions ,
Angel Investors ,
Artificial Intelligence ,
Business Development ,
Business Opportunities ,
Business Strategies ,
Business Valuations ,
Celebrity Endorsements ,
Data Privacy ,
Digital Health ,
Early Stage Companies ,
Endorsements ,
Entrepreneurs ,
Events ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Technology ,
Influencers ,
Innovation ,
Investors ,
IP Portfolio ,
Life Sciences ,
Machine Learning ,
Marketing ,
Med Tech ,
Medical Devices ,
Mergers ,
Partnerships ,
Professional Networking ,
Startups ,
Venture Capital
Wilson Sonsini’s 30th Annual Medical Device Digital Health Conference will address topics of critical importance to medical device and digital health companies today, including key healthcare regulatory considerations, the...more
5/24/2023
/ Acquisitions ,
Angel Investors ,
Artificial Intelligence ,
Business Development ,
Business Opportunities ,
Business Strategies ,
Business Valuations ,
Celebrity Endorsements ,
Data Privacy ,
Digital Health ,
Early Stage Companies ,
Endorsements ,
Entrepreneurs ,
Events ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Technology ,
Influencers ,
Innovation ,
Investors ,
IP Portfolio ,
Life Sciences ,
Machine Learning ,
Marketing ,
Med Tech ,
Medical Devices ,
Mergers ,
Partnerships ,
Professional Networking ,
Startups ,
Venture Capital
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 March 2, 2023, the Federal Trade Commission (FTC) announced a proposed settlement agreement (also referred to as “proposed consent order”) with BetterHelp, Inc., an online counseling service, for allegedly disclosing its...more
On February 1, 2023, the Federal Trade Commission (FTC) announced a complaint against and proposed settlement agreement (the “proposed order”) with GoodRx, a digital health company, over its data sharing practices that...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
COVID-19 has rapidly accelerated our expectations that virtual connection can deliver better and more economical care. As a result, digital health companies have an unprecedented opportunity to innovate, but with that...more
6/2/2022
/ Coronavirus/COVID-19 ,
Data Management ,
Data Privacy ,
Data Protection ,
Digital Health ,
Health Care Providers ,
Healthcare Facilities ,
Personal Data ,
Physicians ,
Popular ,
Telehealth ,
Telemedicine
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