Archives: Regulatory Developments

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Health Care and Life Sciences Industries Still Left in the Dark Following Publication of California Consumer Privacy Act Draft Regulations

Last Thursday, the California Attorney General, Xavier Becerra, released the long-awaited text of the proposed California Consumer Privacy Act (CCPA) regulations. Once finalized, these 24 pages of regulations will govern compliance with the CCPA. While the draft regulations provide insight into how regulated entities must address verification of consumer requests and clarifies aspects of how … Continue Reading

FDA Partners with the National Association of Boards of Pharmacy to Create an Information-Sharing System for Drug Compounding Activities

On October 2, 2019, the United States Food & Drug Administration (FDA) announced that it awarded a cooperative agreement grant to the National Association of Boards of Pharmacy (NABP) to establish an information-sharing system for drug compounding activities conducted in accordance with Section 503A of the Federal Food, Drug, & Cosmetic Act (FDCA). With this … Continue Reading

Join us for a webinar on the state of the California Consumer Privacy Act and what the latest amendments mean for you.

As part of our Countdown to CCPA Compliance webinar series, Reed Smith will be hosting an upcoming webinar, “Countdown to CCPA compliance: 3 months to go” on Wednesday, October 9, 2019 at 2:00 PM ET. This program will explore the outcomes stemming from the September 2019 amendments on the CCPA, as well as the AG’s … Continue Reading

New California ballot initiative would expand protections over health data

Californians may have a new privacy initiative on their November 2020 ballot after the California Privacy Rights and Enforcement Act of 2020 (CPREA) was proposed last week. If enacted, this new law would revise and expand upon the California Consumer Privacy Act (CCPA) – which goes into effect in January – by, among other features, creating heightened standards around the use … Continue Reading

Outsourcing Facility Athenex Withdraws Appeal of District Court’s Ruling on FDA’s Placement of Bulk Drug Substances on its “Clinical Need” List

On September 23, 2019, New York-based outsourcing facility Athenex, Inc. (Athenex) withdrew its appeal of the U.S. District Court for the District of Columbia’s ruling related to the United States Food & Drug Administration’s (FDA) placement of Vasopressin on the Agency’s “clinical need” list. As may be recalled from our previous alert, Athenex sued FDA … Continue Reading

Proposed Rule Offers Clarity on Mandatory Protections for Substance Use Disorder Patient Records

Entities that provide treatment to patients with substance use disorders may find some clarity on federal requirements surrounding patient record confidentiality.  The Department of Health & Human Services (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) recently announced much-anticipated proposed changes to the federal regulations at 42 C.F.R. part 2 (Part 2), which govern … Continue Reading

Recent Traction In FDA’s Development of the 503A and 503B Bulks Lists

Just as the U.S. Food & Drug Administration (“FDA”) promised in its 2019 compounding priorities statement, FDA published a notice and proposed rule in the Federal Register in the past week related to bulk drug substances that can be compounded subject to the conditions of Section 503A and Section 503B of the Federal Food, Drug, … Continue Reading

Malaysia seeks to hold listed companies accountable for implementing anti-corruption framework

It is imperative that life sciences companies operating globally stay on top of anti-corruption developments around the world, which is why we wanted to ensure our clients were aware of recent developments in Malaysia. In late July 2019, the Securities Commission Malaysia announced that it would implement an anti-corruption action plan (the Action Plan) seeking … Continue Reading

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
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