Laws & Regulations

Brazil Unlocks Global Clinical Trials With Regulatory Reforms
Digital Health Brazil Unlocks Global Clinical Trials With Regulatory Reforms

The centralization of ethical reviews under Law 14.874/2024 aims to permanently eliminate the 're-review' culture that has historically stalled large-scale clinical trials. This move marks a fundamental modernization of the Brazilian clinical research landscape, recently highlighted at the

HRSA Approves 10 Drugmakers for New 340B Rebate Pilot Program
Infrastructure & Management HRSA Approves 10 Drugmakers for New 340B Rebate Pilot Program

The federal government has fundamentally altered the financial landscape for safety-net hospitals by approving a new model that replaces upfront drug discounts with a complex backend rebate system. This regulatory pivot marks a departure from decades of established practice, signaling a new era

Can Telehealth Close the Gap in Perinatal Opioid Care?
Digital Health Can Telehealth Close the Gap in Perinatal Opioid Care?

The fear of being reported to child welfare authorities remains a primary deterrent for pregnant women seeking addiction treatment through virtual platforms. As of late 2026, the maternal health landscape is at a critical crossroads as researchers and policy experts call for a standardized

Is Your Health Tech a Trojan Horse for Surveillance?
Regulatory & Compliance Is Your Health Tech a Trojan Horse for Surveillance?

Consumer electronics like smartwatches and fertility apps harvest sensitive biological metrics that lack the federal privacy protections typically afforded by HIPAA-regulated health records. As users strap on their Apple Watches or sync their Oura rings, they often believe their heart rate, sleep

Luminis Health Restores Systems After Month-Long Cyberattack
Regulatory & Compliance Luminis Health Restores Systems After Month-Long Cyberattack

While the MyChart portal is once again accessible for scheduling and messaging, patients may find a significant data gap regarding lab results and physician notes generated during the September outage. This announcement from Luminis Health on September 29 marks the cautious conclusion of a digital

Can Z Codes Solve the Genetic Billing Crisis?
Digital Health Can Z Codes Solve the Genetic Billing Crisis?

The lack of specificity in genetic billing creates a 'wild west' environment where administrative friction and financial exploitation have become commonplace. This fundamental disconnect between rapid scientific innovation and stagnant administrative systems has reached a critical point, as

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