Consumer Data Privacy Act Passed by Senate, but Dies in House

December 31, 2024

Michigan's Personal Data Privacy Act Advances, Raising Stakes for Medtech Industry

The Michigan Senate passed the Personal Data Privacy Act (SB 659) along party lines in lame duck session, moving Michigan a step closer to joining the growing ranks of states that have approved comprehensive privacy and data protection legislation. But the legislation didn’t get taken up by the House and died, meaning that the measure is likely to be reintroduced in 2025.

It would, among other provisions, give consumers the right to opt out of the processing of their personal data for targeted advertising, the sale of personal data, and specified profiling activities, as well as confer data rights found in other states’ laws, including rights of access, correction, deletion, and data portability.


MichBio, along with its partner, AdvaMed, advocated long for inclusion of the following exemption: Sec.11 (3): Information included in a Limited Data Set as described at 45 CFR 164.514(e), to the extent that the information is used, disclosed, and maintained in the manner specified at 45CFR 164.514(e).



That legal speak is a critical inclusion and would permit the transfer of research data between parties and avoid negatively impacting patient care and research and development, especially on the part of medical device manufacturers.


There is no way for medical device manufacturers to tell whether data from certain devices technically falls outside of HIPAA, so all data is treated as though it is protected under HIPAA. The proposed exemption enables medtech companies to continue to support patient care uniformly.


For example, patient data from cardiac monitors used by HCPs who are Covered Recipients under HIPAA is excluded, while patient data from the same model cardiac monitors used by concierge physicians is regulated as health data under this bill with respect to the medtech company even though the company treats data from both devices in the same way.


MichBio and AdvaMed tried to point out that certain consumer rights and regulated entity obligations are inconsistent with how medical devices are utilized in patient care. We expect the bill will be reintroduced in early 2025.

RECENT ARTICLES

April 24, 2025
Prenuptial Patenting: Responsible Engagement with Engineering Firms
April 24, 2025
PharmOptima, a Poratge, Michigan-based preclinical contract research organization (CRO) is advancing drug discovery through its comprehensive suite of services. Specializing in in-vivo ADME/PK, ocular research, as well as regulated large and small molecule bioanalytical and ligand binding services, PharmOptima supports clients in optimizing drug development programs efficiently and effectively. With a staff averaging 11 years of industry experience and multiple individuals with advanced degrees, PharmOptima also boasts one of the most capable and engaging teams in the industry. The company collaborates with board-certified veterinary ophthalmologist Dr. Ryan Boyd, further enhancing its ocular research capabilities. PharmOptima's team of experts is dedicated to providing high-quality services to the pharmaceutical biotechnology industries. Looking ahead, PharmOptima scientists will be presenting posters at the 2025 The Association for Research in Vision and Ophthalmology (ARVO) conference, showcasing their latest research and innovations in ocular drug development. For more information visit www.pharmoptima.com .
April 24, 2025
Two bills, HB 4332 and HB 4333 were recently re-introduced that would prohibit pathogen gain-of-function (GoF) research. Given that the House is now Republican-led raises concerns for MichBio and others that the legislation might gain traction due to misinformation over biosafety and pandemic origins. MichBio opposes such broad legislative bans as they risk undermining critical scientific progress, public health preparedness, and economic innovation. GoF research has been instrumental in developing life-saving therapies and vaccines. For instance, viral vector-based gene therapies, such as Sarepta's Elevidys for Duchenne muscular dystrophy, and oncolytic virotherapies like Amgen's Imlygic for melanoma, rely on genetically modified viruses to deliver therapeutic genes or selectively destroy cancer cells. These advancements stem from GoF methodologies that enhance viral capabilities for therapeutic purposes. Moreover, GoF research has played a pivotal role in vaccine development. Examples like the AstraZeneca and Janssen COVID-19 vaccines and Merck's ERVEBO vaccine against Ebola employs a genetically modified virus to confer protection, underscore the public health benefits derived from GoF studies. ​ Contrary to concerns that GoF research operates without sufficient oversight, multiple layers of regulation are in place. Since 2017, the U.S. Department of Health and Human Services has implemented a framework to evaluate and guide funding decisions for GoF research, particularly those involving potential pandemic pathogens. This framework includes stringent safety protocols, risk assessments, and ethical reviews. ​ MichBio is most concerned that any legislative bans that broadly define and prohibit GoF research risk stifling innovation across various scientific fields. Such bans could inadvertently encompass research in virology, microbiology, molecular biology, and synthetic biology—disciplines vital for developing new therapies, sustainable agricultural practices, and environmental remediation technologies. ​ In turn, state-level bans on GoF research could have detrimental effects on local economies and academic institutions. Such a ban could impede research critical to understanding and combating diseases, leading to a loss of federal and philanthropic funding. This could hamper the growth of the Michigan's biotech and biomedical sectors. ​  MichBio advocates for a balanced approach that reinforces existing oversight mechanisms and fosters transparent, responsible research practices essential to safeguard both public health and scientific progress.