DOJ Pursues Organizations That Falsely Claim Compliance with Medicare’s EHR Incentive Programs

Clinical laboratories that interface with hospital EHR systems under scrutiny by the DOJ could be drawn into the investigations Officials at the federal US Department of Justice (DOJ) continue to pursue fraud cases involving health systems that allegedly have falsely attested to complying with the Medicare and Medicaid electronic health record (EHR) adoption incentive programs (now known as the Promoting Interoperability Programs). This is important for clinical laboratory leaders to watch,...

Sorting through EHR Interoperability: A Modern Day Tower of Babel That Corrects Problems for Clinical Laboratories, Other Providers

Despite the widespread adoption of electronic health record (EHR) systems and billions in government incentives, lack of interoperability still blocks potential benefits of digital health records, causing frustration among physicians, medical labs, and patients Clinical laboratories and anatomic pathology groups understand the complexity of today’s electronic health record (EHR) systems. The ability to easily and securely transmit pathology test results and other diagnostic information among...

New FDA Regulations of Clinical Decision-Support/Digital Health Applications and Medical Software Has Consequences for Medical Laboratories

Softened FDA regulation of both clinical-decision-support and patient-decision-support software applications could present opportunities for clinical laboratory developers of such tools Late 2017, the Food and Drug Administration (FDA) released guidelines on how the agency intends to regulate—or not regulate—digital health, clinical-decision-support (CDS), and patient-decision-support (PDS) software applications. The increased/decreased oversight of the development of these physicians’ tools...

ONC Releases Final Rule for Stage 3 Meaningful Use: What Most Affects Clinical Laboratories and Anatomic Pathology Groups

Meaningful Use Stage 3 focuses on interoperability, which is good news for medical laboratories that must spend time and money to develop effective LIS-EHR interfaces On December 15, 2015, the final rule for Stage 3 meaningful use (MU) went into effect. By now, pathologists and clinical laboratory managers and personnel are well-acquainted with the MU incentive program and the myriad of challenges it presents for almost everyone working in the healthcare sector. Although the implementation of...

Because It Remains Tough to Achieve Interoperability among EHRs, Congress is Proposing Legislation to Resolve That Issue in Ways That May Help Medical Laboratories

One new federal law forbids health IT vendors and providers from deliberately blocking information-sharing with competing EHR systems Several years deep into its effort to get physicians and hospitals to use electronic health record (EHR) systems, the federal government has yet to come up with a way to improve interoperability—the ability of EHRs to interface and communicate with other systems. Stage one and stage two Meaningful Use guidelines have failed to successfully address the barriers...
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