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Proposed FDA Rule over Laboratory Developed Tests Puts Lab Innovation at Risk
On September 29, 2023, the FDA proposed a rule to tighten control over Laboratory Developed Tests (LDTs), supplanting the CMS as regulators. While supporters emphasize the need for safety, critics, especially in the medical community, fear the rule could stifle innovation, jeopardizing independent laboratories and escalating healthcare costs.
Read MoreIn the Age of Generative AI, Will the Insatiable Need for Data Trigger a Reckoning for Healthcare?
Several weeks ago, I had the honor of sitting among some of the finest minds in healthcare and engineering to learn about the Future of Digital Health presented by the Center for Health Innovation at UCSD Health. Funded in large part by San Diego philanthropists Joan and Irwin Jacobs, the Center intends to be a driving force in the transformation of healthcare.
Read MoreThe Protecting Access to Medicare Act of 2014 (PAMA) for Laboratories: What You Need to Know
Congress passed the Protecting Access to Medicare Act (PAMA) in 2014. The purpose was to ensure millions of seniors could maintain access to critical health services, however the reality is that Congress was looking for an offset to previously mandated cuts to reimbursement for Physicians which were regularly exempted each year by Congress. PAMA “limited” cuts to laboratories at 10% in each of year one through three, and 15% in each of the following three years.
Read MoreThe True Cost of Traditional Lab-EHR Integrations
Automation and real-time data exchange are critical tools to advance quality care and reduce cost in healthcare. That said, more than 50% of diagnostic labs still operate using paper forms. The true cost of those paper forms is at least $30 per order.
Read MoreInformation Blocking: What You Need to Know
In 2016, the Federal Government enacted the 21st Century Cures Act (the Cures Act), to enhance patient access to their medical records, promote seamless communication across healthcare providers, and automate the secure exchange of patient information across disparate software platforms and systems.
Read MoreThe True Cost of Paper Forms
Despite national efforts and billions in funding to automate the healthcare industry, more than 50% of all lab tests are still processed on paper.
Read MoreWith COVID Test Funding Gone, Diagnostic Labs Consider Their Next Move
Diagnostic laboratories are now beginning to navigate a post-COVID market, absent federal funding, and heightened testing demand.
Read MoreHealthcare Has Outgrown the EHR
Accelerated by a worldwide pandemic and a tectonic shift toward telehealth and at-home care, the future of healthcare will demand the connection of multiple data sources to provide full visibility to a patient’s medical history.
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