Insights

The evolving health technology regulatory landscape can be challenging to navigate. Below, we give health tech developers a quick glance at national level efforts that are important to understand for your business strategy.

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The Good, Bad and Ugly on Information Blocking Regulations

Are you building an application that allows an individual or a provider a comprehensive view of a person’s health care journey? Have you run into data access barriers when trying to link into a person’s health data from a hospital system’s electronic health record (EHR) system?  The federal government will soon release new rules that may open access to this coveted data – helping you provide a fuller value to your company’s digital health solution. 

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FDA Wants You – Wearable Data for Drug and Device Safety Surveillance

Health tech disruptors creating in-home monitoring and wearable technologies that collect health data may be interested to know that the FDA is getting into the business of what they call “Real World Data (RWD).” RWD is data, often collected directly from the user or patient and provides information on  their health beyond a clinical encounter, like a visit to the doctor. This month the FDA awarded over $200 million to fund the next five years of their drug surveillance data program, The Sentinel Initiative. 

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Where Health IT Stakeholders Stand (Part 2): CMS Rules on Data Interoperability, Conditions of Participation and More.

This February, draft federal rules on health data interoperability, information blocking, health IT certification, and health data exchange related to Medicare/Medicaid conditions of participation were proposed by the Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health IT (ONC). After releasing these proposed new rules CMS and ONC opened the field to comments and questions from interested and invested parties such as health care companies, providers, and current and future patients.

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Where Health IT Stakeholders Stand (Part 1): ONC Rules on API’S, Information Blocking and Data Exchange

Since this past February, many health IT companies have been reviewing, commenting on, and trying to understand the business model and production implications of the newly proposed Federal rules on health data interoperability, information blocking, health IT certification, and health data exchange related to Medicare/Medicaid conditions of participation. If your business touches the health IT sector and you haven’t been following these rules, you should be—the final versions of these rules will be game changers for the health IT sector.

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How You Can Influence Laws – A Forgotten Business Strategy

It’s probably been a long time since you were knowledgeable about civic processes, but as a business owner the knowledge of how a bill becomes law  can be foundational to your business’s strategic trajectory — knowing when and how to influence policy and regulation can have significant impacts on your bottom line.

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Engaging Regulatory Agencies To Advance Your Business’s Interests

By now, you’ve got a solid understanding of a health IT entrepreneur’s strategic business need to stay abreast of health data regulations as they’re developed.  If you understand the connection between regulatory alignment and business growth but are wondering “When should I engage in reviewing, responding to, and influencing regulations?

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The New Data Sharing Landscape: What Tech Developers Need to Know (Part 1)

This is a big week for those who care (or should care!) about health data tech regulation. The day before the biggest health IT conference of the year, HIMSS, the U.S. Department for Health and Human Services (HHS) dropped two highly anticipated draft rules—one outlining the seven exceptions to information blocking (i.e. when does not sharing data not count as information blocking) and the other requiring health plans to release Medicare and Medicaid claims data through openly published Health Level Seven (HL7®) Fast Healthcare Interoperability Resources (FHIR®)–based Application Programing Interfaces (APIs).

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Health Consulting

Regulatory alignment for the next generation of health tech companies

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