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.

Health Consulting

Preparing for the Permanency of Virtual Care

Since the COVID-19 shelter-in-place orders were announced across the US in March, the use of virtual care technologies for patient visits within ambulatory clinics has increased from under 10% to over 70%.  During the first weeks of March, providers scrambled to simply find any virtual care technologies to help keep their “doors” open to their patients.

Continue reading »

Health IT Company to Pay $145 Million for Violating Federal Law

Last week, Practice Fusion, an electronic health records (EHR) company, was fined $145 million for setting up a business arrangement that violated the federal Anti-Kickback Statute. This law prevents anyone from offering, soliciting, paying, or receiving anything of value in order to induce referrals or generate federal healthcare business.

Continue reading »

Understand RCM to succeed in the RPM market

Remote patient monitoring (RPM) devices – fitness watches, blood pressure, cardio monitors – are growing in popularity as a way to gather and correlate data outside of a traditional clinical setting and share up-to-the-minute data with care providers.

Continue reading »

Catching the Flu’s Data

Almost a third of the US population will travel during the holidays. With flu season already in full swing, tracking flu outbreaks is vital to caregivers of small children and the elderly, in addition to those with compromised immunity.

Continue reading »

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. 

Continue reading »

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. 

Continue reading »

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.

Continue reading »
Health Consulting

Regulatory alignment for the next generation of health tech companies

© 2021 Elevation Health Consulting. All Rights Reserved. Privacy Notice