Over the counter (OTC) drugs are medicines sold directly to consumers without a prescription from a healthcare professional. Traditionally, the range of OTC drugs has been limited to medical diseases and conditions for which...more
The 21st Century Cures Act enacted the Regenerative Medicine Advanced Therapy (RMAT) designation in recognition of the growing importance of regenerative therapies. Qualifying for RMAT designation conveys significant...more
Recently, President Donald Trump signed into law the Right to Try Act of 2018 (RTTA).1 The RTTA represents the federal version of laws previously passed by a majority of the states, but with important differences. This WSGR...more
Evaluating Prospective Partners When Scaling Your Digital Health Company (Part 1) -
Picture this: You have built a digital health company that could revolutionize healthcare delivery; upend diagnostic processes; accelerate...more
6/1/2018
/ Colleges ,
Digital Health ,
Due Diligence ,
Health Care Providers ,
Intellectual Property Protection ,
IP License ,
Joint Venture ,
Medical Devices ,
Partnerships ,
Software Developers ,
Technology Sector ,
Universities ,
Venture Capital
Recently, the Centers for Medicare & Medicaid Services (CMS) decided to provide nationwide reimbursement for certain in vitro, companion diagnostic tests that employ Next Generation Sequencing (NGS) for patients with advanced...more
Machine Learning and Digital Health Applications -
The use of artificial intelligence (AI) algorithms to solve complex problems has risen dramatically in the last several years. In 2017, Gartner identified more than 1,000...more
3/9/2018
/ Digital Health ,
Health Care Providers ,
Innovative Technology ,
Life Sciences ,
Mayo v. Prometheus ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Personal Data ,
PHI ,
Section 101
The U.S. Food and Drug Administration (FDA) recently issued draft guidance on obtaining "Qualified Infectious Disease Product" (QIDP) designation for antibacterial and antifungal drug candidates intended to treat serious or...more
Life Beyond FDA Clearance or Approval: The Reimbursement Challenge -
To medical device manufacturers, winning premarket approval or 510(k) clearance from the U.S. Food and Drug Administration (FDA) is only half the battle....more
1/11/2018
/ Corporate Financing ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Health Insurance ,
Initial Public Offering (IPO) ,
Life Sciences ,
Medical Devices ,
Medicare ,
Pharmaceutical Industry ,
Popular ,
Reimbursements ,
Venture Capital
Digital health—the convergence of healthcare, devices, genomics (in some instances), and digital technology—is a fast-growing sector teeming with the promise to improve the health of millions of people. A key feature of...more
12/22/2017
/ Apple Watch ,
Centers for Medicare & Medicaid Services (CMS) ,
Digital Health ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Devices ,
Medicare ,
Mobile Apps ,
Telemedicine
Recently, the U.S. Food and Drug Administration (FDA) issued final guidance on deciding when to submit a new 510(k) premarket notification application for a change to an existing medical device. The guidance is far reaching...more
The U.S. Food and Drug Administration (FDA) recently released draft guidance on the new "Breakthrough Devices Program," which was established by the 21st Century Cures Act. This new program supersedes and combines features of...more
Digital health is the convergence between healthcare, genomics, and digital technologies. It is a fast-growing sector with important implications for individuals and institutions alike. Whether it is hospitals and health...more
11/9/2017
/ 21st Century Cures Act ,
Acquisitions ,
Digital Health ,
Emerging Growth Companies ,
Emerging Technology Companies ,
Health Care Providers ,
Medical Devices ,
Patents ,
Pharmaceutical Industry ,
Software ,
Trade Secrets ,
Warranties ,
Wearable Technology
Recently, the China Food and Drug Administration (CFDA) issued a policy proposal linking drug approval to patent rights.1 The proposal is intended to promote innovation in the development of both drugs and medical devices and...more
Factoring in Human Factors -
According to a recent British Medical Journal research report, the mean rate of death from medical error in U.S. hospitals is estimated to be over 251,000 people per year. Though many medical...more
Consumer Digital Health: Market Shift Is Leading to New Opportunities -
The newest wave of consumer digital health investment focuses on applications encouraging consumers to change health-related behaviors, shifting...more
On December 13, 2016, President Obama signed the 21st Century Cures Act (H.R. 34) into law. The act's 312 pages contain a variety of provisions, including nearly $5 billion in funding for scientific research, $1 billion in...more
After several high-profile defeats in both district and circuit courts involving the off-label promotion of regulated products and the First Amendment, the U.S. Food and Drug Administration (FDA) is now engaged in a...more
The U.S. Food and Drug Administration (FDA) recently launched a website1 that will now make it easier to report allegations of medical device manufacturer misconduct to the agency.2 Misconduct reports were historically...more
Dietary supplements are big business. A recent estimate pegs the U.S. market for dietary supplements at over $35 billion annually. The U.S. Food and Drug Administration (FDA) estimates the number of dietary supplements to be...more
On August 8, 2016, the U.S. Food and Drug Administration (FDA) issued draft guidance on the important topic of deciding when to submit a new 510(k) premarket notification application (510(k)) for a change to an existing...more
The Future of Innovation in Medtech: An Industry in Search of Growth While Facing Pressures to Consolidate in a Post-ACA World -
In the Affordable Care Act (ACA) era, the healthcare industry has witnessed significant...more
For years, the U.S. Food and Drug Administration (FDA) has taken the position that a medical device (or drug) manufacturer that promotes an FDA-approved device (or drug) for an unapproved use violates the Federal Food, Drug,...more
1/28/2016
/ Amarin ,
Anti-Kickback Statute ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Interstate Commerce ,
Jury Instructions ,
Medical Devices ,
Off-Label Promotion
Ten Considerations for Companies Evaluating a Pre-Negotiated Acquisition -
In recent years, there has been a shift in the research and development strategy of large pharmaceutical and medical device companies from...more
The Patient Protection and Affordable Care Act's (ACA) 2.3 percent medical device excise tax was contentious even before taking effect on January 1, 2013. Under the ACA, medical device manufacturers and importers are required...more
The Office of Inspector General (OIG) for the Department of Health and Human Services recently released its Semiannual Report to Congress. Through the first three quarters of 2015, OIG announced recoveries of $3.35 billion...more