In the past five years, medical device companies have faced continuous change, with new regulations, evolving standards, and increasing documentation requirements. The 2024 MTI Regulatory Report put it plainly: “time and bandwidth” have now overtaken cost as the biggest challenge for regulatory affairs teams.
This shift points to a deeper issue. The volume and pace of regulatory change have outgrown traditional compliance approaches. Tracking updates and reacting as they come is no longer
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Health IT & Digital Health-Opinion | Op-Eds | Guest Columns | Analysis, Insights - HIT Consultant
Disconnected Systems Are Undermining Hospital Foodservice — and Patient Care
Hospital foodservice might not immediately spring to mind when you think of the patient experience. Yet, for patients, meals are one of the few opportunities to exercise choice— something that matters deeply in a setting where most decisions are made for them. Three times a day, the people who deliver those meals offer something rare in healthcare—a reason to smile.
For hospital foodservice teams, the daily demands are relentless, and expectations remain high. Unfortunately, many teams
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How Sensor Technology Is Transforming Clinical Trials
Clinical trials are the foundation of drug development, generating life-saving medicines for the betterment of society. But trials can be arduous, lengthy, and expensive for patients, sites, and sponsors, particularly in neurological disease trials, where phase III trials cost up to $370 million, last 7.9 years, and face a 95% failure rate among drug candidates 1,2,3. Moreover, traditional site-based data collection methods do not capture the complete picture of how patients are affected by
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Ledger Lines to Neural Nets: Re-engineering Medical Coding for the GPU Age
In 1971, a small team at Boston’s Beth Israel Hospital, led by Dr. Howard Bleich and Dr. Warner Slack, booted up the hospital’s first Center for Clinical Computing. Their PDP-11 minicomputer stored lab results and a few hundred ICD-8 codes on nine-track tape. Each evening, residents lined up to run charge‐slip reports and marvel at the glow of the terminal. Fifty years later, we still tabulate charges, but the code set has grown from those few hundred entries to nearly 70,000 in ICD-10-CM,
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Build Smart, Not Fast: What the FDA Really Cares About in Digital Therapeutics
Digital therapeutics (DTx) are revolutionizing healthcare — from smart inhalers to virtual therapy avatars. As more patients turn to DTx apps, companies rush to deliver innovative features. But in the race to innovate, many developers neglect vital elements of success, leading to major setbacks, especially when seeking FDA approval. It’s time to find a practical path forward to mitigate risk and scale smarter.
The Digital Therapeutics Trifecta:
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Breaking the Silence: Using AI to Empower Men to Seek Help for Mental Health
In a world where strength is often measured by stoicism, millions of men are suffering in silence. The statistics around male suicide paint a sobering picture: men die by suicide at nearly four times the rate of women, making it one of the leading causes of death among men — particularly those in their middle years.
Despite this alarming reality, less than half of men experiencing depression, anxiety, or other mental health conditions will ever seek professional help. The
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Beyond the Hype: Building AI Systems in Healthcare Where Hallucinations Are Not an Option
As a technologist and entrepreneur who has spent decades architecting enterprise-grade AI systems across highly regulated industries, I’ve seen firsthand the chasm between AI’s promise and its practical risks, especially in domains like healthcare, where trust is not optional and the margin for error is razor-thin. Nowhere is the cost of a hallucinated answer higher than at a patient’s bedside.
When an AI system confidently presents false information—whether in clinical decision
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The Crucial Role of Integrated Infusion and Specialty Pharmacy Services in Health Systems
In today’s rapidly evolving healthcare landscape, patients expect high-quality, convenient healthcare that caters to their unique needs and preferences. In order to meet patient expectations and thrive in a competitive care environment, health systems need to create seamless care pathways that enable patients to receive the treatments they need, without having to leave the health system. Two of the most promising areas of opportunity for health systems in this regard are infusion and specialty
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Five Strategies for Strengthening Data Security in Healthcare
While digitalization has revolutionized healthcare delivery, patients now entrust clinicians with sensitive health information under the expectation that it will remain private and protected. This trust — crucial yet fragile — is grounded in the assurance of data security and confidentiality. However, because electronic health records (EHRs) hold large volumes of protected health information (PHI), they are attractive targets for cybercrime, including phishing and ransomware. As a result,
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Building a Better Future Through Collaboration: How Payer-Provider Partnerships Are Transforming Healthcare
The success stories emerging from payer-provider collaborations offer a hopeful counterpoint to the fragmentation and frustration so often heard about in healthcare. These strategic alignments between payers, providers, and health IT vendors prove that streamlined operations, better care delivery, and stronger financial outcomes are not just possible but repeatable.
Each year, the KLAS K2 Collaborative Points of Light report highlights real-world partnerships that have delivered measurable
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