This is going to be a busy rulemaking season for the government and healthcare technology developers. The Unified Agenda, a summary of all coming proposed and final rules from the Department of Health and Human Services (“DHHS”), shows a flurry of activity that health IT developers should be alert to. Please note, all dates are … Continue reading Regulatory Alert for Health IT Developers →

Many healthcare technology developers deliver their products as “cloud-based Software as a Service (‘SAAS’).” This is software that is generally accessed online through a browser. Many SaaS providers use a multi-tenant architecture for all their customers, or have several multi-tenant architecture for different types of customers. In this environment, all customers are basically using the … Continue reading SaaS With Class →

When a technology developer terminates its relationship with a hospital, medical group, or other healthcare organization, there are several issues it needs to manage. As a developer, your legal obligations are going to arise from three sources: HIPAA; The 21st Century Cures Act and its implementing obligations; and, Your contract(s), including and especially your Business … Continue reading Important Considerations when Breaking Up with Healthcare Customers →

This post will discuss what constitutes a product’s nonconformity with the Office of the National Coordinator’s (“ONC”) Health IT Certification Program, and what the consequences look like. Certification covers product capabilities that include data capture, structuring charts, e-prescribing, information exchange, analytics and reporting. The certification criteria for any specific capability may include requirements or required … Continue reading Health IT Certification: When It Goes Wrong →

There are several legal barriers to true “interoperability” in the sense that policymakers use the word. Generally, when a member of the executive or legislative branch talks about an interoperable health IT ecosystem, they mean one in which the patient essentially has a single record that they can carry with them from one shop to … Continue reading How the Law Holds Back Data Exchange in Healthcare →

The phone rings. A tired hospital administrator picks it up. An equally tired patient barks into the phone “what the *&@! do I have to do to get my $(!)! health record out of you people? Don’t mail me a 1,000 pages, send me my electronic record.” Both of them hate those few moments and … Continue reading It’s Not Your Health Record Or Your Data →

If you sell healthcare technology, you might reasonably ask whether you can have software referral programs, contribute to your customers’ charities, pay folks to write reviews for your software, and more. In many software verticals, these practices are commonplace. However, for healthcare technology developers, these practices are radioactive because they may implicate the Anti-Kickback Statute … Continue reading How To Sell Healthcare Technology Without Going To Jail →

This post will cover how healthcare technology vendors can proactively manage the risk that the Anti-kickback Statue (“AKS”) presents them, with a specific focus on contracting with healthcare providers. Two other major areas of risk are: 1) the sales and marketing processes, and 2) when partnering to co-develop or push product that is somehow reimbursable … Continue reading The Anti-kickback Statute & Healthcare Technology Contracts →

I invite you to Google the top healthcare software/technology firms and look at the mission statements in each one. There is a really good chance that most of them mention improving clinical care and value-based reimbursement, or use similar verbiage. That’s because one of the only reasons a healthcare provider or system will even consider … Continue reading The Coming MIPS Cost Crunch →