California Adopts “Click to Cancel” Law to Regulate Consumer Subscriptions

California has just adopted the new “click to cancel” law that will regulate consumer subscriptions, along with memberships and other autorenewing or continuous service arrangements with consumers. AB 2863 amends California’s existing autorenewal law to add additional protections for consumers with respect to autorenewing or continuous billing charges. Digital health companies need to be aware…

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Kristie Prinz to Lead New Silicon Valley Group in ProVisors

I am pleased to announce that I am a new ProVisors home group leader in the Silicon Valley Region.  I will be leading the new Silicon Valley Virtual 1 Group, which will be an all-virtual home group for service providers engaged in Silicon Valley business.  The group will meet the first Friday of the month…

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Kristie Prinz to Speak at Practicing Law Institute Program

The Silicon Valley Digital Health Law Blog’s Kristie Prinz of The Prinz Law Office will be speaking at an upcoming one-day Practicing Law Institute Program to be held on October 9, 2024 at the PLI headquarters in San Francisco, California. Kristie will be speaking on “Drafting Privacy Policies for Devices with No User Interface –…

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California Telehealth Policy Coalition Presents Webinar on Cross-State Licensure and Compacts

The California Telehealth Policy Coalition presented a webinar last week on cross-state licensure and compacts, which provided an excellent overview of ongoing efforts in California and other states in facilitating cross-state licensure for physicians and other licensed providers.  The webinar is now publicly available for viewing at the following link: https://www.cchpca.org/resources/cross-state-licensure-compacts-webinar/.  The powerpoint is also…

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FTC Sues Software Company over Annual Paid Monthly Subscription Contract

The FTC has just taken enforcement action against a software company over its subscription contracting practices, filing a complaint against Adobe over its Annual Paid Monthly subscription contract and its consumer practices regarding the contract. A copy of the FTC complaint is linked here.  If your digital health company relies on a subscription-based revenue model,…

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Digital Health AI Start-Ups Concerned as California’s AI Legislation Moves Closer to Adoption

Many digital health AI start-ups are concerned as California’s controversial AI legislation moves closer to adoption by the California legislature.  The legislation is SB 1047: Safe and Secure Innovation for Frontier Artificial Intelligence Models Act, and it would impose unprecedented new regulations on the development of AI.  A full copy of the bill has been linked…

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The Prinz Law Office Announces Launch of New Subscription Plans

The Prinz Law Office is pleased to announce the launch of a new subscription plan, which is intended to simplify the process of working with a lawyer for companies as well as individuals.  The firm’s subscription plans have been been designed to uniquely enable clients to hire and communicate with counsel without the fear or…

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HHS Publishes Proposed Rule Defining Information Blocking Penalties for Medical Providers

The Department of Health and Human Services (“HHS”), the Office of the National Coordinator for Health Information Technology (“ONC”) and the Centers for Medicare & Medicaid Services (“CMS”) have just published a proposed rule defining the consequences for medical providers who fail to comply with the new information blocking regulations. HHS previously established information blocking…

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DEA Extends COVID-19 Telemedicine Rules

The Drug Enforcement Administration (“DEA”), jointly with the Department of Health and Human Services (“HHS”), has announced that the current telemedicine regulations will continue in place through the end of December 31, 2024.  To view the full text of the announcement, please click here.  The full text of the extension is available here. The decision…

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FDA Releases Final Guidance on Cybersecurity for Medical Devices

The Food and Drug Administration (“FDA”) has issued final guidance to advice developers on their compliance obligations for premarket submissions.  To view the FDA’s finalized document, please click here: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (fda.gov).   The guidance issued by the FDA supersedes the earlier draft guidance issued on…

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HHS Issues Final Rule Implementing Information Blocking Penalties

The Department of Health and Human Services Office of Inspector General (“HHS-OIG”) recently issued on June 27, 2023 its final rule on information blocking penalties.  The final rule establishes statutory penalties for committing information blocking of up to a $1 million penalty per violation.  According to an HHS website, enforcement assessing penalties began as of…

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HIPAA Privacy Rule Update on Reproductive Health Anticipated

The final update to the HIPAA Privacy Rule on reproductive health is anticipated to be issued soon by the Department of Health and Human Services (“HHS”). HHS issued a Notice of Proposed Rulemaking on April 17, 2023 to solicit comments on its proposal to modify the Standards for Privacy of Individually Identifiable Health Information (“Privacy…

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ATA releases Toolkit Intended to Advise on Eliminating Disparities in Healthcare

The American Telemedicine Association has just released a new toolkit intended to help with assessing the impact of telehealth on addressing disparities in healthcare among communities.  Please click here to view the ATA Press Release, which announces the release and explains the significance. The toolkit, which was developed by an ATA advisory group, provides functionality…

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DEA Considers Regulations on the Prescribing of Controlled Substances via Telemedicine

The DEA conducted a two day listening session last week to receive practitioner comments on  regulations relating to the prescribing of controlled substances via telemedicine.   Transcripts of the public comments are available for viewing at this link:  https://www.deadiversion.usdoj.gov/Telemedicine_listening_session.html. According to reporting by Fierce HealthCare, the listening sessions were held in response to a backlash from…

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New HIPAA Security Rule Assessment Tool Released

If your company is currently subject to, or alternatively, may be subject in the future to HIPAA security requirements, you may be interested to know that the Office for Civil Rights (“OCR”) and the Office of the National Coordinator for Health Information Technology (“ONC”) have just released an updated version of their security assessment tool,…

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California Considers Adoption of Controversial Veterinary Telehealth Bill

The California legislature is currently considering a controversial new telehealth bill that would dramatically expand the access to veterinary care for animal patients located in California.  AB 1399 would change California’s existing law to permit a veterinarian-client-patient-relationship to be established solely via telemedicine.   Existing California law limits the practice of veterinary telemedicine to existing veterinarian-client-patient-relationships…

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Kristie Prinz to Present on Best Practices in Drafting Digital Health SaaS Contracts to Add & Retain Customers

Date: November 14, 2023 Price: $99 General Admission; $125 Late Admission Registration The digital health industry has exploded during the COVID-19 pandemic, resulting in an increasing number of digital health SaaS transactions. However, given the relative youth of the industry, few business lawyers or businesspeople negotiating digital health SaaS transactions are familiar with the best…

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The Risks of Closing a Deal by Signing the Customer Contract

Perhaps one of the very worst decisions I see digital health companies make is negotiating to close a deal by agreeing to sign the customer’s contract. While it can potentially save time and upfront legal fees to agree to sign the customer’s proposed contract and perhaps get cash in the door faster, the legal fallout…

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Talk with an Expert Series: Beau Fernald Shares Software Implementation Best Practices

  Silicon Valley Digital Health Law Blog’s Kristie Prinz recently sat down for an interview with Beau Fernald, Fractional COO and Principal of Aware Insights LLC to discuss the topic of software implementation. One of the most common drafting mistakes in digital health and software contracts is failing to sufficiently define the parties’ mutual expectations…

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Best Practices in Drafting Digital Health SaaS Contracts to Add & Retain Customers

The digital health industry has exploded during the COVID-19 pandemic, resulting in an increasing number of digital health SaaS transactions. However, given the relative youth of the industry, few business lawyers or businesspeople negotiating digital health SaaS transactions are familiar with the best practices to pursue in negotiating and drafting digital health contracts. Silicon Valley…

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Introduction to Negotiating and Drafting SaaS Contracts

Date: June 17, 2022 Time: 10 a.m. PST Price:  $175.00  Register How are SaaS agreements unique from other technology contracts? What do you need to know to negotiate and draft them? Silicon Valley SaaS lawyer Kristie Prinz will present an introductory webinar on “Introduction to Negotiating & Drafting SaaS Contracts,” on June 17th at 10 a.m.…

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