Archives: Regulatory Developments

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Newly introduced bill could provide for additional protections for biological data collected by non-covered entities

Over the past few years, genetic testing services have become a widespread phenomenon. Companies providing these services gather certain biological data from consumers who sign up for their services and then analyze this data to ascertain information about the consumer’s ancestry and/or genetic traits, among other things. These companies, however, are typically considered “non-covered entities” … Continue Reading

HIPAA-Regulated Entities Take Notice – States are Teaming Up on Enforcement

In an unprecedented settlement arising from a federal lawsuit in the U.S. District Court for the Northern District of Indiana, a medical software provider agreed to pay $900,000 to 16 state attorneys general (AGs) for alleged violations of a conglomerate of state and federal privacy laws. The settlement represents the resolution of the first-ever multistate data … Continue Reading

DOJ Issues Opinion on FDA Jurisdiction Over Articles Used in Lawful Executions

The Department of Justice’s (DOJ) Office of Legal Council (OLC) released an opinion in May 2019 addressing the Food and Drug Administration’s (FDA) jurisdiction over drugs used in capital punishment. A result of a request by the U.S. Attorney General’s Office, the OLC issued an opinion following years of conflict around the use of sodium … Continue Reading

Five Key Takeaways from OCR’s Proposed Rule to Scale Back the Non-Discrimination Requirements Applicable to Health Care Entities

The Department of Health & Human Services (HHS) Office for Civil Rights (OCR) recently issued a proposed rule (Proposed Rule) that would significantly scale back the non-discrimination regulations applicable to health care entities under the authority of Section 1557 of the Affordable Care Act (ACA). This Proposed Rule, issued on May 24, 2019 and scheduled … Continue Reading

OCR Clarifies Direct Liability of Business Associates Under HIPAA

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) released a new fact sheet outlining and clarifying violations of HIPAA (Health Insurance Portability and Accountability Act of 1996) for which a business associate can be held directly liable. Published shortly after the release of new guidance from OCR in the form … Continue Reading

CNIL Imposes Penalty to Optical Center; French Highest Administrative Court Reduces Amount

Life sciences companies doing business in France will be interested in the recent results of Optical Center’s appeal of a penalty assessed by the Commission nationale de l’informatique et des libertés, the French data protection authority, surrounding a data breach. The data breach allowed access to invoices and purchases containing personal and sensitive customer data. … Continue Reading

Health Apps and HIPAA – Recent FAQs Highlight Importance of Covered Entities and Business Associates Scrutinizing their Relationships with App Developers

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) released a new set of HIPAA FAQs addressing the applicability of HIPAA to certain health apps and the covered entities and business associates that interact with them. These FAQs build upon prior guidance from OCR that outlined the framework for evaluating whether a … Continue Reading

FDA Announces Public Hearing on Regulation of Cannabis and Cannabis-Derived Products

The Food and Drug Administration (FDA) will hold a public hearing on May 31, 2019, “to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.”1 This offers those within the cannabis industry a unique opportunity to speak on their concerns and interests … Continue Reading

Join Us for a Webinar on “GDPR: Live”

The Global Data Protection Regulation (GDPR), the new European data privacy regulation that will have world-wide reach, goes into effect on May 25, and will significantly affect life sciences companies. If you have been wondering what life is going to look like in a GDPR world, please join Reed Smith attorneys Cynthia O’Donoghue, Dr Andreas … Continue Reading

FDA Announces Plans to Improve Safety and Advance Innovation of Medical Devices

On April 17, 2018, FDA announced its plan to launch the Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health (Action Plan), which aims to support and advance innovation in medical devices while also assuring the safety of the devices throughout their Total Product Life Cycle (TPLC). To that end, FDA intends to focus … Continue Reading

Join us for A Webinar on “Global Data Protection Regulation (GDPR) – Three Months to Go”

In three months, the new European data privacy regulation – with a world-wide reach and draconian sanctions for non-compliance – takes effect. Are you ready? Join Reed Smith on Thursday, February 22, 2018 for an informative CLE webinar discussing key priorities and strategies for compliance during the final three months remaining before the GDPR takes … Continue Reading

No (Expensive) Lunch For You! New NJ Regulation Caps Payments To Doctors

Last month, New Jersey joined several other states in adopting a new regulation limiting payments and gifts that can be made by pharmaceutical manufacturers to health care providers. The regulation caps include a maximum of $10,000 per calendar year for a prescriber’s bona fide services, and $15 per meal. Additional information about this new regulation … Continue Reading

Is Your Software a Medical Device? FDA Weighs-in with New Draft Guidances

On December 8, 2017 – nearly a year after President Obama signed into law the 21st Century Cures Act (“Cures Act”) – the Food and Drug Administration (“FDA”) released two new draft guidances that aim to implement section 3060 of the Cures Act, and provide clarity on the Agency’s regulatory approach to software as a … Continue Reading

FDA Finalizes Policy for Sharing Patient-Specific Data from Medical Devices

FDA recently released guidance (“Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request”) finalizing its policy on medical device manufacturers sharing patient-specific information from devices with patients at the patients’ request. In response to the more active roles patients are playing in their health care, and increased frequency with which patients are seeking … Continue Reading

FDA Sets the Stage for Cures Act Breakthrough Devices Program in Highly Anticipated Guidance Document

On October 25, 2017, FDA released a critical draft guidance on the breakthrough medical device pathway established by the 21st Century Cures Act (the “Cures Act”). The Draft Guidance For Industry, Breakthrough Device Pathway (“Draft Guidance”) reflects FDA’s proposal regarding the process by which a sponsor may seek a designation as a breakthrough device, assigning … Continue Reading

The FDA Releases Enhanced Regulatory Initiatives for Drug Compounders

On September 26, 2017, FDA Commissioner Scott Gottlieb, M.D. released a statement about FDA’s ramped up regulatory initiatives for drug compounders. These initiatives include: (1) publishing a report that provides a list of all the drugs that outsourcing facilities have compounded; (2) publishing a guide entitled “Outsourcing Facility Information,” which is a compilation of key … Continue Reading

FDA Clarifies Trading Partners Under the DSCSA

The Federal Food and Drug Administration (“FDA”) recently published a draft guidance to assist industry and State and local governments in understanding how to categorize entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (“DSCSA”). The DSCSA establishes product tracing, licensure, reporting, and other requirements for certain trading partners … Continue Reading

Final Rule on Amending the Anti-Kickback Safe Harbors and Civil Monetary Penalty Rules on Beneficiary Inducements

On December 7, 2016, the Office of Inspector General of the Department of Health and Human Services published a final rule amending the safe harbors to the Anti-Kickback Statute (AKS) and the Civil Monetary Penalty (CMP) rules prohibiting beneficiary inducements. These changes protect certain practices and arrangements from criminal prosecution or civil sanctions under the … Continue Reading

CMS Finalizes Two-Track System to Implement Significant Changes in Medicare Physician Payment Policies Under MACRA

The Centers for Medicare & Medicaid Services (CMS) has finalized sweeping reforms of the Medicare physician fee schedule (MPFS) update framework, as mandated by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Beginning in 2017, physicians can choose one of two tracks within its “Quality Payment Program” to determine their MPFS update: reporting … Continue Reading

Significant Changes for Long-Term Care Facilities Participating in Medicare and Medicaid Programs Issued by CMS

The Centers for Medicare & Medicaid Services (CMS) issued a final rule on September 28, 2016, comprehensively updating and extensively revising the requirements for participation (ROPs) for long-term care (LTC) facilities participating in the Medicare and Medicaid programs (the Final Rule). As the first major update to the requirements for LTC facilities in 25 years, the … Continue Reading

Off-Label Promotion And The First Amendment Updates

Although activity around the Amarin and Pacira cases has settled down, questions regarding the FDA’s position on truthful off-label promotion-and whether it comports with First Amendment free speech principles—persist. The FDA has announced a two-day public hearing on November 9 and 10, 2016 regarding “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.”  In-person … Continue Reading

FDA Mandates Black Box Warnings For Opioids And Benzodiazepines

The Food and Drug Administration (FDA) recently decided to require so-called “black box warnings” on nearly 400 products, warning of the risks of combining certain opioid medications and central nervous system depressants called benzodiazepines. Opioids are a class of powerful, pain-reducing medications that include oxycodone, fentanyl, and morphine.  Certain prescription cough suppressants also contain opioids.  … Continue Reading

Please Join Us For A Reed Smith Webinar On 3D Printing – Will Regulatory Pathways and Reimbursement Change?

The Reed Smith Life Sciences Health Industry Group will be hosting an upcoming CLE webinar “Think Differently. 3D Printing – Will Regulatory Pathways and Reimbursement Change?” on July 21 , 2016 at 12:00 p.m. ET. Reed Smith presenters Gail Daubert, Celeste Letourneau and Kevin Madagan will be discussing the increasing popularity of 3D printing and … Continue Reading
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