Archives: Regulatory Developments

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COVID-19 pandemic: FCC issues guidance on the TCPA’s “emergency purposes exception”

The Telephone Consumer Protection Act (the TCPA) restricts telemarketing and the use of automated telephone equipment for phone calls, faxes, and text messages. In an effort to ease restrictions in light of the COVID-19 outbreak, the Federal Communications Commission (FCC) has issued guidance clarifying that informational calls that are directly related to the imminent health or safety … Continue Reading

Medical Device Manufacturers Could Be Affected by Recent CMS Guidance to Health Care Providers

Medical device manufacturers, who may already be seeing the effects of lessened demand stemming from a slow-down of elective procedures outside of the United States, should be aware of recent guidance the U.S. Centers for Medicare and Medicaid Services (CMS) issued to health care providers urging limitations on elective surgeries and nonessential procedures. As an … Continue Reading

Health Care Providers, Health Plans, and Health IT Developers Sharing Patient Data Likely Impacted by New Final Rules

Certain health care providers, health information technology (IT) developers, and health plans could see the way they share patient information transformed following the release of two new final rules issued by the U.S. Department of Health and Human Services. The rules address interoperability and information blocking. Reed Smith partner Nancy Bonifant Halstead and senior associate … Continue Reading

United States federal and state rules and regulations during public health emergencies: navigating novel coronavirus

On January 30, 2020, the World Health Organization (WHO) declared novel coronavirus (also known as “2019-nCoV” and “SARS-CoV-2”) a Public Health Emergency of International Concern, and the United States Department of Health and Human Services (HHS) named it a public health emergency (PHE). In the United States, the declaration of a PHE empowers HHS to … Continue Reading

FDA announces information collection on “Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion”

On January 28, 2020, the Food and Drug Administration (FDA) announced that the Office of Prescription Drug Promotion (OPDP) will conduct two studies to examine how payment disclosure statements and the types of endorsers in drug advertisements affect consumers’ understanding of the information provided in the advertisements. Below is a summary of the studies. FDA … Continue Reading

Health care and life sciences companies may gain clarity from proposed amendment to California Consumer Privacy Act (CCPA)

Proposed amendment AB 713, if passed, would hopefully provide clarity to businesses working with clinical research data. The amendment proposes matching CCPA de-identification standards to those set forth in the Health Insurance Portability and Accountability Act (HIPAA), in addition to equally important clarifications for life sciences companies, health care providers and medical researchers. In particular, … Continue Reading

FDA’s Section 804 Prescription Drug Importation Program and 801(d)(1)(B) Guidance

On December 23, 2019, the U.S. Food and Drug Administration (FDA) published in the Federal Register a set of proposed rules covering the requirements and procedures for importing under Section 804 of the federal Food, Drug, and Cosmetic Act (FDCA) prescription drugs from Canada. It is these proposed rules under which prescription drugs intended for … Continue Reading

FDA publishes new draft guidance on animal drug compounding

As 2019 comes to an end, the United States Food & Drug Administration’s (“FDA” or the “Agency”) Center for Veterinary Medicine has published a new draft Guidance for Industry #256, “Compounding Animal Drugs from Bulk Drug Substances” (the “Draft Guidance”).  The Draft Guidance addresses FDA’s regulatory approach to compounding animal drugs from bulk drug substances.  … Continue Reading

Social Security Numbers available on public-facing website and lack of timely remedial efforts lead to $1.6 million civil monetary penalty against Texas state agency

The U.S. Department of Health and Human Services Office for Civil Rights’ (OCR) recent imposition of a civil monetary penalty (CMP) against a Health Insurance Portability and Accountability Act of 1996 (HIPAA) covered entity demonstrates the need to ensure that HIPAA compliance programs are in place, are audited regularly, and emphasize the importance of promptly … Continue Reading

The Drug Enforcement Administration amends regulations applicable to registrants ordering certain controlled substances

The Drug Enforcement Administration (“DEA” or the “Administration”) recently published a notice in the Federal Register (volume 84, number 189, pages 51368–51377) that the Administration is amending its regulations and issuing a final rule to implement not only a new single-sheet format for its DEA Form 222, but to improve the corresponding recordkeeping requirements for … Continue Reading

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
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