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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New California Law to Mandate Release of VC Investment Diversity Information

Governor Newsom has just signed SB 54, which will require venture capital firms in the state of California to annually report the diversity of founders they are backing.  According to Tech Crunch’s reporting, SB 54 will result in amendments to the Business and Professional Code and also will amend part of the Government Code pertaining…

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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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Will Your Digital Health Company’s Contracts be Vulnerable to a Recession?

If your digital health company is like most companies right now, your company is nervous about the possibility of an impending recession.  Of course, the real challenge is how to handle those nerves, and what steps your digital health company should take to better protect itself in the current environment.  The conventional wisdom is to…

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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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The Prinz Law Office Adopts New Fixed & Subscription Billing Options

I am excited to announce that my firm is adopting a number of new options for working with our clients. We received feedback asking for new fixed rate and subscription packages for specific business scenarios, and in response to that feedback we have designed a variety of new packages designed around those requests. These options…

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Arbitration vs. Litigation in Digital Health Contracts: Which Option is “Better”?

I was recently asked by a client whether arbitration or litigation was “better.”  The issue had been raised by an attorney on the other side of the contract, who had not only tried to persuade my client to revise the specific clause in that case, but had also provided my client the unsolicited advice that…

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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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Introduction to Software Contracts Workshop for Lawyers

Date: May 21, 2022 Time: 9:00 a.m. PST Price: $699    Register Are you a lawyer who would like to expand your practice niche into the software transactions area? Would you like to know the basics about negotiating and drafting these types of agreements? Join Silicon Valley Digital Health Lawyer Kristie Prinz in an introductory software…

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Intro to Software Contracts for NonLawyers

Date: May 23, 2022 Time: 9 a.m. PST Price: $699  Register How are software contracts unique from other business contracts? What do you need to know to negotiate them? Silicon Valley Digital Health Lawyer Kristie Prinz will be teaching an introductory workshop on software contracts negotiation for nonlawyers. The virtual workshop will be interactive and…

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Introductory Digital Health Contracts Workshop for Lawyers

Date: June 6, 2022 Time: 9 a.m. PST Price: $699 Register   Are you a lawyer who would like to expand your practice niche into the digital health area?  Would you like to know the basics about negotiating and drafting these types of agreements? Join Digital Health Lawyer Kristie Prinz in an introductory digital health contracts…

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Introduction to Digital Health Contracts Workshop for Non-Lawyers

Date: June 18, 2022 Time: 9 a.m. PST Price:  $699   Register How are digital health contracts unique from other business contracts? What do you need to know to negotiate them? Silicon Valley Digital Health Lawyer Kristie Prinz will be teaching an introductory workshop on digital health contracts negotiation for nonlawyers. The virtual workshop will be…

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Introduction to Digital Health Contracts

Date & Time: May 16, 2022, 10 a.m. PST Price: $150 Early Bird, $175 General, $195 Last Minute, $350 Group/Department Register Eventbrite How are digital health contracts unique from other business contracts? What do you need to know to negotiate them? Silicon Valley Digital Health Lawyer Kristie Prinz will present an introductory webinar on May…

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Digital Health Lawyer Kristie Prinz Presents on Negotiating Digital Health Contracts

How are digital health contracts unique from other business contracts? What do you need to know to negotiate them? Silicon Valley Digital Health Lawyer Kristie Prinz will present an introductory webinar on May 16th at 10 a.m. PST on “Introduction to Negotiating Digital Health Contracts” which will provide an overview of the basic concepts you…

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Drafting Problems with Fee Terms in Digital Health Contracts

When a client sends me a digital health software agreement to review or update, I always make a priority of reviewing any terms in the contract involving fees and then carefully reviewing the website and any marketing materials or fee schedules to confirm that the fee terms in the contract clearly match the fees listed…

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Why Digital Health Companies Should Plan for Customer Negotiations over Insurance Requirements

If your digital health company is like most, you postpone the procurement of insurance policies until you absolutely have to obtain them, expecting to be able to obtain whatever you need on demand.  You likely do not consider that not having certain insurance in place may delay the signing of your next big customer contract.…

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Key Mistakes Companies Make in Negotiating Digital Health Software Contracts

What are the key mistakes companies make when negotiating digital health software contracts? First and foremost, the most common mistake I run into negotiations is that companies often end up negotiating with the wrong contract as the starting point.  For example, the parties may negotiate from a software license template when they need a SaaS…

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Is Your Digital Health Agreement Silent on Implementation?

If your digital health company is like most companies these days, you likely set up a software interface and train your customers on how to use the product at the very beginning of the relationship.  You probably even charge some sort of fee for these initial services that you provide.  And the set-up process may…

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How to Recognize a Poorly Written Digital Health Contract

In my experience, the first sign of a poorly drafted digital health contract is that contract completely confuses the software licensing and SaaS technology models, so that it’s extremely unclear as to what kind of product that the software provider is actually selling. If the product is a software license, the contract should contain a…

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Is your Digital Health Software Company Signing Customers to Contracts Based on the Appropriate Contract Model?

Is your digital health software company signing customers to contracts that are based on the appropriate technology contracting model? In digital health contracts (as in software contracts generally), perhaps the single most common issue that gets confused is the difference between a software license and a software-as-a-service agreement.  But the concepts are very different.  In…

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When does a Digital Health Company need a Service Level Agreement?

I often find that many digital health companies are unfamiliar with the concept of a service level agreement and have no idea when they might need one. A “service level agreement” or “SLA” is a technical agreement that defines that parties’ expectations of the level of service that will be provided in a particular service…

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Is Digital Health Software Subject to FDA Regulation?

If you work in the software industry, you may be surprised to discover that digital health software products may be subject to regulation by the Food and Drug Administration (“FDA”).  Some software is considered a software as a medical device (“SaMD”) product or software in a medical device (“SiMD”) product. So, how do you know…

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What is the Concept of “Digital Health”?

What is the concept of “Digital Health”?  If you work in the field and are still unsure of how exactly to define the term, then you are in good company: while there seems to be some consensus regarding what is included in the concept of “Digital Health,” there is still some confusion on the scope…

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Negotiating Consulting Services Agreements in an Uncertain Economy

Date & Time: December 30, 2020, 10-11:30 a.m. PST Price:  $150 General Admission, $175 Last Minute & On-Demand Register on Eventbrite With the continued economic uncertainty resulting from COVID-19 and ongoing disruptions to large sectors of the worldwide economy, what are the current best practices to adopt in the negotiation of SaaS agreements? Silicon Valley…

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Introduction to Negotiating & Drafting SaaS Agreements

Date & Time: December 14, 2020, 10-11:30 a.m. PST Price:  $150 General Admission, $175 Last Minute & On-Demand Register on Eventbrite 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 December 14,…

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Best Practices for Negotiating SaaS Agreements in an Uncertain Economy

Date & Time: December 8, 2020, 10-11:30 a.m. PST Price:  $150 General Admission, $175 Last Minute & On-Demand Register on Eventbrite With the continued economic uncertainty resulting from COVID-19 and ongoing disruptions to large sectors of the worldwide economy, what are the current best practices to adopt in the negotiation of SaaS agreements? Silicon Valley…

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