Archive for 2023
HHS Publishes Proposed Rule Defining Information Blocking Penalties for Medical Providers
The Department of Health and Human Services (“HHS”), the Office of the National Coordinator for Health Information Technology (“ONC”) and the Centers for Medicare & Medicaid Services (“CMS”) have just published a proposed rule defining the consequences for medical providers who fail to comply with the new information blocking regulations. HHS previously established information blocking…
Read MoreDEA Extends COVID-19 Telemedicine Rules
The Drug Enforcement Administration (“DEA”), jointly with the Department of Health and Human Services (“HHS”), has announced that the current telemedicine regulations will continue in place through the end of December 31, 2024. To view the full text of the announcement, please click here. The full text of the extension is available here. The decision…
Read MoreNew California Law to Mandate Release of VC Investment Diversity Information
Governor Newsom has just signed SB 54, which will require venture capital firms in the state of California to annually report the diversity of founders they are backing. According to Tech Crunch’s reporting, SB 54 will result in amendments to the Business and Professional Code and also will amend part of the Government Code pertaining…
Read MoreFDA Releases Final Guidance on Cybersecurity for Medical Devices
The Food and Drug Administration (“FDA”) has issued final guidance to advice developers on their compliance obligations for premarket submissions. To view the FDA’s finalized document, please click here: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (fda.gov). The guidance issued by the FDA supersedes the earlier draft guidance issued on…
Read MoreHHS Issues Final Rule Implementing Information Blocking Penalties
The Department of Health and Human Services Office of Inspector General (“HHS-OIG”) recently issued on June 27, 2023 its final rule on information blocking penalties. The final rule establishes statutory penalties for committing information blocking of up to a $1 million penalty per violation. According to an HHS website, enforcement assessing penalties began as of…
Read MoreHIPAA Privacy Rule Update on Reproductive Health Anticipated
The final update to the HIPAA Privacy Rule on reproductive health is anticipated to be issued soon by the Department of Health and Human Services (“HHS”). HHS issued a Notice of Proposed Rulemaking on April 17, 2023 to solicit comments on its proposal to modify the Standards for Privacy of Individually Identifiable Health Information (“Privacy…
Read MoreATA releases Toolkit Intended to Advise on Eliminating Disparities in Healthcare
The American Telemedicine Association has just released a new toolkit intended to help with assessing the impact of telehealth on addressing disparities in healthcare among communities. Please click here to view the ATA Press Release, which announces the release and explains the significance. The toolkit, which was developed by an ATA advisory group, provides functionality…
Read MoreDEA Considers Regulations on the Prescribing of Controlled Substances via Telemedicine
The DEA conducted a two day listening session last week to receive practitioner comments on regulations relating to the prescribing of controlled substances via telemedicine. Transcripts of the public comments are available for viewing at this link: https://www.deadiversion.usdoj.gov/Telemedicine_listening_session.html. According to reporting by Fierce HealthCare, the listening sessions were held in response to a backlash from…
Read MoreNew HIPAA Security Rule Assessment Tool Released
If your company is currently subject to, or alternatively, may be subject in the future to HIPAA security requirements, you may be interested to know that the Office for Civil Rights (“OCR”) and the Office of the National Coordinator for Health Information Technology (“ONC”) have just released an updated version of their security assessment tool,…
Read MoreCalifornia Considers Adoption of Controversial Veterinary Telehealth Bill
The California legislature is currently considering a controversial new telehealth bill that would dramatically expand the access to veterinary care for animal patients located in California. AB 1399 would change California’s existing law to permit a veterinarian-client-patient-relationship to be established solely via telemedicine. Existing California law limits the practice of veterinary telemedicine to existing veterinarian-client-patient-relationships…
Read MoreKristie Prinz to Present on Best Practices in Drafting Digital Health SaaS Contracts to Add & Retain Customers
Date: November 14, 2023 Price: $99 General Admission; $125 Late Admission Registration The digital health industry has exploded during the COVID-19 pandemic, resulting in an increasing number of digital health SaaS transactions. However, given the relative youth of the industry, few business lawyers or businesspeople negotiating digital health SaaS transactions are familiar with the best…
Read MoreThe Risks of Closing a Deal by Signing the Customer Contract
Perhaps one of the very worst decisions I see digital health companies make is negotiating to close a deal by agreeing to sign the customer’s contract. While it can potentially save time and upfront legal fees to agree to sign the customer’s proposed contract and perhaps get cash in the door faster, the legal fallout…
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