Law/Legal
Here's a look at documents from law firms and legal groups
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Hooper, Lundy and Bookman Issues Commentary: FDA's New Digital Health Guidance Signal Shift for Wellness Devices and CDS
LOS ANGELES, California, Jan. 10 -- Hooper, Lundy and Bookman, a law firm, issued the following commentary on Jan. 9, 2026:
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FDA's New Digital Health Guidance Signal Shift for Wellness Devices and CDS
On January 6, 2026, the Food and Drug Administration (FDA) released updated guidance on Clinical Decision Support Software, as well as General Wellness: Policy for Low Risk Devices, providing clarity to an industry grappling with innovation and regulatory expectations. Both guidance documents contain additional explanation from the FDA on the definitions and applicable regulations which apply
... Show Full Article
LOS ANGELES, California, Jan. 10 -- Hooper, Lundy and Bookman, a law firm, issued the following commentary on Jan. 9, 2026:
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FDA's New Digital Health Guidance Signal Shift for Wellness Devices and CDS
On January 6, 2026, the Food and Drug Administration (FDA) released updated guidance on Clinical Decision Support Software, as well as General Wellness: Policy for Low Risk Devices, providing clarity to an industry grappling with innovation and regulatory expectations. Both guidance documents contain additional explanation from the FDA on the definitions and applicable regulations which applyto general wellness products and clinical decision support (CDS) software. While FDA notes the guidance is nonbinding and merely represents the FDA's current recommendations and statutory interpretations, it is intended to provide an understanding of what enforcement actions the Administration will undertake. The guidance is part of a larger initiative from the Trump Administration to both deregulate and encourage use of digital health products. Although the guidance limits those products under FDA's regulatory purview, it will be important for providers to be aware of where their devices fall within regulatory definitions as the digital health policy landscape continues to adapt to its current pressures through further policymaking.
General Wellness Products
The FDA's Center for Devices and Radiological Health released updated guidance (last revised in 2019) for low-risk general wellness products. The agency specifically defines general wellness products as those that relate to maintaining a general state of health or the role of a healthy lifestyle to reduce the risk of certain chronic diseases. These products also must present a low risk to the safety of users.
Building off its previous guidance, FDA describes its categories of intended uses in two ways, (1) those claiming to sustain or improve functions associated with a general state of health that do not make any reference to diseases or condition, such as weight management, physical fitness, stress management, mental acuity, self-esteem, sleep management or sexual function and (2) those that make reference to diseases or conditions and are intended to help reduce the risk of and manage certain chronic conditions. The FDA guidance establishes a standard that products must not be invasive, implanted, or pose a risk to the safety of the user.
The guidance responds to an increased need for clarification that certain non invasive sensing features in wearables--such as optical sensors that estimate blood pressure, oxygen saturation, blood glucose trends, or heart rate variability--may be treated as general wellness products, rather than medical devices, when the products are intended only for wellness-related use. The FDA provides specific examples of wrist-warn wearables and their applications.
The FDA emphasized that the goal of the guidance is to give companies clear boundaries so that devices that simply provide information--without presenting themselves as medical-grade tools--can operate without FDA oversight. This effort aligns with the Administration's interest in the use of wearables as part of its Make America Health Again initiative, seeking to use innovative means to manage and prevent chronic disease and overall health.
Clinical Decision Support Software
Additionally, FDA released updated guidance (last revised in 2022) outlining a more permissive approach to certain types of clinical decision support (CDS) software, signaling a notable shift from its earlier regulatory stance. The new guidance specifies categories of lower risk CDS tools that will fall outside the scope of medical device regulation, while also clarifying which software functions will continue to be treated as devices.
To qualify as a non device function and therefore not be subject to FDA regulation, CDS software must be:
1. "not intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system;
2. intended for the purpose of displaying, analyzing, or printing medical information about a patient or other medical information;
3. intended for the purpose of supporting or providing recommendations to a health care professional about prevention, diagnosis, or treatment of a disease or condition; and
4. intended for the purpose of enabling such health care professional to independently review the basis for such recommendations that such software presents so that it is not the intent that such health care professional rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient."
The new guidance clarifies the third criterion for CDS software functions that are excluded from the definition of a medical device under the Food, Drug and Cosmetic Act. The FDA will not enforce regulatory requirements for software that provides a single clinically appropriate recommendation, provided the other criteria are met. Previously, non-device software could only provide a list of treatment recommendations. FDA lists examples that would be subject to enforcement discretion.
Under the FDA guidance, examples of non-device CDS functions include tailored clinician order sets, matching patient medical information, drug formulary guidelines, drug interaction notifications, reminders for preventative care, patient discharge papers, and lists of follow-up options. Examples of items that remain within medical device oversight include software that uses patient images to generate treatment plans, tools that analyze imaging data for surgical planning, and systems that process multiple physiological signals from wearables to detect events such as heart attacks or narcolepsy episodes.
Outlook
The guidance further underscores the Trump Administration's efforts to promote digital health innovation, building on prior announcements, such as the FDA's Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot and the Center for Medicare and Medicaid Innovation's (CMMI's) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model which would expand access to new technology-supported care to manage chronic disease. Of note, both updated guidance documents were issued without an opportunity to comment beforehand, limiting input. Stakeholders may submit comments for the FDA to consider at any time, but those comments may not be acted upon by the agency until the document is next revised or updated.
-- Monica Massaro and Claire Ernst
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Professional
Monica Massaro
Principal, Government Relations & Public Policy
Washington, D.C.
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Claire Ernst
Director, Government Relations & Public Policy
Washington, D.C.
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Original text here: https://hooperlundy.com/fdas-new-digital-health-guidance-signal-shift-for-wellness-devices-and-cds/
[Category: BizLaw/Legal]
Vorys Elevates Six Attorneys to Partner
COLUMBUS, Ohio, Jan. 9 -- Vorys, Sater, Seymour and Pease, a law firm, issued the following news:
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Vorys Elevates Six Attorneys to Partner
Vorys is pleased to announce that six attorneys -- Brian Baxter, Daniel Bross, Brian Dressel, Robert Grise, Thomas Whaling and Ryan Wheeler -- became partners on January 1, 2026.
COLUMBUS
Brian Dressel is a member of the firm's labor and employment group. His practice focuses on a wide range of employment law matters. Brian has significant experience litigating a variety of employment cases, including discrimination, retaliation, trade secrets, wage-and-hour
... Show Full Article
COLUMBUS, Ohio, Jan. 9 -- Vorys, Sater, Seymour and Pease, a law firm, issued the following news:
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Vorys Elevates Six Attorneys to Partner
Vorys is pleased to announce that six attorneys -- Brian Baxter, Daniel Bross, Brian Dressel, Robert Grise, Thomas Whaling and Ryan Wheeler -- became partners on January 1, 2026.
COLUMBUS
Brian Dressel is a member of the firm's labor and employment group. His practice focuses on a wide range of employment law matters. Brian has significant experience litigating a variety of employment cases, including discrimination, retaliation, trade secrets, wage-and-hourand FMLA matters. He has litigated matters in the Public Utilities Commission of Ohio and the Ohio Supreme Court. He is also a member of the firm's appellate subgroup and has litigated several appeals in state and federal courts.
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Thomas Whaling is a member of the firm's litigation group. He represents individuals and companies in a wide variety of litigation matters, including complex business, commercial and contract litigation. Tom's practice includes an emphasis on the construction industry, in which he advises owners, developers and contractors on disputed matters ranging from breach of contract claims and change orders to bonding, liens, delays and more. Tom also leads the firm's cannabis, hemp and CBD practice.
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Ryan Wheeler is a member of the Vorys eControl group. His practice focuses on eCommerce, brand protection, product diversion and intellectual property enforcement. Ryan counsels numerous consumer products manufacturers and brands around the world on strategies to strengthen their eCommerce business and avoid third-party disruption to their sales and distribution channels.
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CINCINNATI
Brian Baxter is a member of the firm's corporate group. His practice focuses on representing both public and private companies in corporate and transactional matters, including mergers and acquisitions, securities, periodic reporting and disclosure and corporate governance. He has represented Fortune 500 companies and other publicly listed companies in acquisitions and a range of other transactional matters across manufacturing, banking, transportation and other industries.
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Daniel Bross is a member of the firm's finance, energy and real estate practice group. His practice focuses on real estate financing transactions and general real estate matters, with experience in the development and sale of office buildings, lab and medical research buildings, apartment projects, industrial facilities and other commercial properties. He has particular experience representing lenders, owners and developers in Low-Income Housing Tax Credit (LIHTC) transactions.
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Robert Grise is a member of the Vorys eControl group. His practice focuses on counseling manufacturers and brands on issues related to eCommerce and online brand protection, including developing strategies to assist companies with product distribution issues, product diversion, unauthorized importation of grey market goods and counterfeit sales. He helps to protect clients' brand reputation and value, allowing them to focus attention on expansion and growth.
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About Vorys: Vorys was established in 1909 and currently has nearly 375 attorneys in 10 offices in Ohio, Washington, D.C., Texas, Pennsylvania, California, London and Berlin. Vorys currently ranks as one of the 200 largest law firms in the United States according to American Lawyer magazine.
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Original text here: https://www.vorys.com/news-vorys-elevates-six-attorneys-to-partner-in-2026
[Category: BizLaw/Legal]
Planert and Thomas to Speak at Sold-Out Advanced Topics in Customs Compliance Conference 2026
MINNEAPOLIS, Minnesota, Jan. 9 [Category: BizLaw/Legal] -- Taft, a law firm, issued the following news:
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Planert and Thomas to Speak at Sold-Out Advanced Topics in Customs Compliance Conference 2026
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Will Planert, partner, and E.J. Thomas, senior associate in Taft's International Trade practice, will be featured speakers at the Advanced Topics in Customs Compliance Conference in Houston on February 5, 2026. Taft is also proud to serve as a Gold Sponsor of this premier industry event, which has been sold out for weeks and will draw hundreds of importers and trade compliance professionals
... Show Full Article
MINNEAPOLIS, Minnesota, Jan. 9 [Category: BizLaw/Legal] -- Taft, a law firm, issued the following news:
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Planert and Thomas to Speak at Sold-Out Advanced Topics in Customs Compliance Conference 2026
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Will Planert, partner, and E.J. Thomas, senior associate in Taft's International Trade practice, will be featured speakers at the Advanced Topics in Customs Compliance Conference in Houston on February 5, 2026. Taft is also proud to serve as a Gold Sponsor of this premier industry event, which has been sold out for weeks and will draw hundreds of importers and trade compliance professionalsfrom across the United States.
At the conference, Planert and Thomas will present "Navigating the AD/CVD Minefield: A Survival Guide for Trade Compliance Professionals." Antidumping and Countervailing Duties (AD/CVD) remain among the most complex and consequential areas of U.S. trade compliance, with potentially significant cost and liability implications for importers. Their session will equip attendees with practical guidance to navigate today's increasingly aggressive enforcement landscape.
Will Planert is a Partner in the International Trade practice, representing foreign corporations and U.S. importers in trade remedy proceedings and customs matters. He routinely appears before the U.S. Department of Commerce, International Trade Commission, and U.S. Customs and Border Protection, with litigation experience at the U.S. Court of International Trade, Federal Circuit, and USMCA panels. Will also advises clients on customs compliance, USMCA origin issues, country of origin issues, classification, Section 232, and other tariffs issued by the Executive Branch.
E.J. Thomas is a Senior Associate in the International Trade practice, advising clients across industries on antidumping, countervailing duty, and various tariff proceedings before the U.S. Department of Commerce and International Trade Commission. He provides guidance on Section 232, Section 301, IEEPA tariffs, and tariff mitigation strategies, and handles U.S. Customs matters such as ruling requests, prior disclosures, protests, audits, and Uyghur Forced Labor Prevention Act reviews. E.J. has helped clients secure tariff exclusions and has litigated related denials. He also represents clients in disputes before the U.S. Court of International Trade, Federal Circuit, and NAFTA/USMCA panels.
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Original text here: https://www.taftlaw.com/news-events/news/planert-and-thomas-to-speak-at-sold-out-advanced-topics-in-customs-compliance-conference-2026/
Mia L. Garcia Shares Cannabis Legal Updates With Northeast Ohio Municipal Judges Association
CLEVELAND, Ohio, Jan. 9 -- Frantz Ward, a law firm, issued the following news:
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Mia L. Garcia Shares Cannabis Legal Updates with Northeast Ohio Municipal Judges Association
Partner Mia L. Garcia recently shared key cannabis industry legal updates in her presentation, "From Possession to Policy: Evolving Trends in Cannabis Law," for the Northeast Ohio Municipal Judges Association.
In her presentation, Mia discussed:
* Constitutional considerations for search and seizure related to an odor of marijuana as demonstrated by Supreme Court cases in Ohio and other states.
* Comparisons between
... Show Full Article
CLEVELAND, Ohio, Jan. 9 -- Frantz Ward, a law firm, issued the following news:
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Mia L. Garcia Shares Cannabis Legal Updates with Northeast Ohio Municipal Judges Association
Partner Mia L. Garcia recently shared key cannabis industry legal updates in her presentation, "From Possession to Policy: Evolving Trends in Cannabis Law," for the Northeast Ohio Municipal Judges Association.
In her presentation, Mia discussed:
* Constitutional considerations for search and seizure related to an odor of marijuana as demonstrated by Supreme Court cases in Ohio and other states.
* Comparisons betweenIssue 2 (Ohio's voter-approved marijuana legalization measure) and Senate Bill 56 regarding possession, transportation, and public use of marijuana.
* The status of hemp-derived consumables, including drinkable cannabinoid products, in Ohio and throughout the nation.
With a focus on complex regulatory frameworks, Mia advises clients on navigating the nuances of cannabis regulation, licensing, and operational issues. She represents operators in the medical and adult-use cannabis markets and in the hemp industry, supporting license acquisition, regulatory dispute resolution, zoning and municipal law, and mergers and acquisitions.
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Original text here: https://www.frantzward.com/mia-l-garcia-shares-cannabis-legal-updates-with-northeast-ohio-municipal-judges-association/
[Category: BizLaw/Legal]
Faegre Drinker Biddle and Reath Issues Commentary: Roth Catch Up Contribution Requirement and a Statutory Merger
MINNEAPOLIS, Minnesota, Jan. 9 -- Faegre Drinker Biddle and Reath, a law firm, issued the following commentary on Jan. 7, 2026:
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Roth Catch Up Contribution Requirement and a Statutory Merger
Spotlight on Benefits blog
Authors: Page D. Fleeger and Mark P. Rosenfeld
As the Roth catch-up contributions become effective this month, issues not addressed in the final regulations are coming to light.
Question: Our company completed a statutory merger -- how does that impact the Roth catch-up contributions requirement?
Answer: Based on past IRS guidance, it is more than likely that an employee
... Show Full Article
MINNEAPOLIS, Minnesota, Jan. 9 -- Faegre Drinker Biddle and Reath, a law firm, issued the following commentary on Jan. 7, 2026:
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Roth Catch Up Contribution Requirement and a Statutory Merger
Spotlight on Benefits blog
Authors: Page D. Fleeger and Mark P. Rosenfeld
As the Roth catch-up contributions become effective this month, issues not addressed in the final regulations are coming to light.
Question: Our company completed a statutory merger -- how does that impact the Roth catch-up contributions requirement?
Answer: Based on past IRS guidance, it is more than likely that an employeeof either company in a statutory merger that was subject to the Roth catch-up contribution requirements of SECURE 2.0 Act prior to the statutory merger will continue to be subject to the Roth catch-up contribution requirements after the merger. Similarly, if the statutory merger occurs midyear, the employee's compensation for the year of the merger will include compensation paid by either entity.
The material contained in this communication is informational, general in nature and does not constitute legal advice. The material contained in this communication should not be relied upon or used without consulting a lawyer to consider your specific circumstances. This communication was published on the date specified and may not include any changes in the topics, laws, rules or regulations covered. Receipt of this communication does not establish an attorney-client relationship. In some jurisdictions, this communication may be considered attorney advertising.
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Meet the Authors
Page D. Fleeger
Partner
Minneapolis
+1 612 766 7230
page.fleeger@faegredrinker.com
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Mark P. Rosenfeld
Partner
Minneapolis
+1 612 766 8882
mark.rosenfeld@faegredrinker.com
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Original text here: https://www.faegredrinker.com/en/insights/publications/2026/1/the-roth-catch-up-contribution-requirement-and-a-statutory-merger
[Category: BizLaw/Legal]
Carlucci Quoted in Legal Tech News
MINNEAPOLIS, Minnesota, Jan. 9 [Category: BizLaw/Legal] -- Taft, a law firm, issued the following news:
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Carlucci Quoted in Legal Tech News
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Taft's Matt Carlucci was quoted in "Legal Tech's Predictions for Artificial Intelligence in 2026," which was published on Law.com. The article examines the predictions of legal industry experts regarding how AI will influence legal services, transform the legal business, and impact the courts and law in 2026.
In the article, Carlucci predicts that AI will become normalized as a "junior associate," with attorneys increasingly using it as a critical
... Show Full Article
MINNEAPOLIS, Minnesota, Jan. 9 [Category: BizLaw/Legal] -- Taft, a law firm, issued the following news:
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Carlucci Quoted in Legal Tech News
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Taft's Matt Carlucci was quoted in "Legal Tech's Predictions for Artificial Intelligence in 2026," which was published on Law.com. The article examines the predictions of legal industry experts regarding how AI will influence legal services, transform the legal business, and impact the courts and law in 2026.
In the article, Carlucci predicts that AI will become normalized as a "junior associate," with attorneys increasingly using it as a criticalreviewer that critiques reasoning and arguments and warns that lawyers who resist adoption will be outpaced by peers who embrace AI.
Read the full article here.
Carlucci is a corporate attorney whose practice focuses on advising high-growth companies and their private equity, growth capital, and venture capital investors on a range of corporate matters, including M&A and financing rounds. He also supports emerging companies throughout the corporate lifecycle, from early-stage funding to growth equity financings, bolt-on acquisitions, and exits.
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Original text here: https://www.taftlaw.com/news-events/news/carlucci-quoted-in-legal-tech-news/
Berger Montague Investigates Reports That Elon Musk's Chatbot Grok Creates Nonconsensual Pornographic Images of Women and Children
PHILADELPHIA, Pennsylvania, Jan. 9 -- Berger Montague, a law firm, issued the following news:
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Berger Montague Investigates Reports that Elon Musk's Chatbot Grok Creates Nonconsensual Pornographic Images of Women and Children
Berger Montague, a leading national plaintiffs' law firm, is investigating claims that xAI's chatbot Grok is being used for the large-scale unauthorized creation of lewd and sexually abusive images of women and underage girls, which are published on Grok's official account on the social media website X, formerly Twitter.
"These reports of exploitation are disturbing,"
... Show Full Article
PHILADELPHIA, Pennsylvania, Jan. 9 -- Berger Montague, a law firm, issued the following news:
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Berger Montague Investigates Reports that Elon Musk's Chatbot Grok Creates Nonconsensual Pornographic Images of Women and Children
Berger Montague, a leading national plaintiffs' law firm, is investigating claims that xAI's chatbot Grok is being used for the large-scale unauthorized creation of lewd and sexually abusive images of women and underage girls, which are published on Grok's official account on the social media website X, formerly Twitter.
"These reports of exploitation are disturbing,"said Shareholder E. Michelle Drake. "Sexual humiliation by a chatbot shouldn't be the price for a woman existing online. The idea that underage girls may be subject to this disgusting abuse of technology is unconscionable."
According to ABC News, Elon Musk's companies xAI and X face global backlash over Grok's production of sexually explicit deepfake depictions of real women and children without their consent. On Tuesday Britian's top technology official demanded X take urgent action. The European Union, France, India, Malaysia and Brazil have also condemned the platform. NBC News has also reported the phenomenon.
If you or a family member has been victimized by a sexually explicit picture created by Grok without consent and you would like to learn about your legal options, you can contact Berger Montague at completing this form, emailing us at info@bergermontague.com,or by calling us at 1-800-424-6690. For more information please visit www.bergermontague.com/grok. Berger Montague is one of the nation's preeminent law firms focusing on complex civil litigation, class actions, and mass torts in federal and state courts throughout the United States. With more than $2.4 billion in 2025 post-trial judgments alone, the Firm is a leader in the fields of complex litigation, antitrust, consumer protection, defective products, environmental law, employment law, securities, and whistleblower cases, among many other practice areas. For over 55 years, Berger Montague has played leading roles in precedent-setting cases and has recovered over $50 billion for its clients and the classes they have represented. Berger Montague is headquartered in Philadelphia and has offices in Chicago; Malvern, PA; Minneapolis; San Diego; San Francisco; Toronto, Canada; Washington, D.C., and Wilmington, DE.
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Original text here: https://bergermontague.com/news/berger-montague-investigates-reports-that-elon-musks-chatbot-grok-creates-nonconsensual-pornographic-images-of-women-and-children/
[Category: BizLaw/Legal]
