Archive for February 2022
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…
Read MoreWhy 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.…
Read MoreKey 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…
Read MoreIs 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…
Read MoreHow 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…
Read MoreIs 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…
Read MoreWhen 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…
Read MoreIs 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…
Read MoreWhat 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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