• HIPAA and Patient Information Privacy: What You Need to Know

    HIPAA and Patient Information Privacy: What You Need to Know

    Due to the massive amount of personal data and information stored electronically today, everybody is concerned about their patient information privacy. That is why you may find yourself questioning what your doctor is doing to ensure the protection of your healthcare information.Health plans, health care providers, health care clearinghouses, and their business associates have to abide by set industry standards when it comes to the storage and transmission of your healthcare information. However, some entities don’t have to follow these regulations. These include:State agencies such as child protective servicesLaw enforcement... Read More

  • What is Current Good Manufacturing Practices Compliance (cGMP)?

    What is Current Good Manufacturing Practices Compliance (cGMP)?

    In the United States, Current Good Manufacturing Practices (cGMP) are the Food and Drug Administration’s (FDA) formal regulations regarding the design, monitoring, control, and maintenance of manufacturing processes and facilities. The word “current” was added to signal to companies that they needed to remain up to date with the latest technologies, not rely on what was a good practice ten years ago.cGMPs are followed by pharmaceutical and biotechnology companies to ensure that their items are manufactured to specific requirements including identity, strength, quality, and purity. Good Manufacturing Practices are regulated... Read More

  • The FDA’s Race To Catch Up With Digital Medicine

    The FDA’s Race To Catch Up With Digital Medicine

    The Food and Drug Administration announced an initiative in June, which would ramp up regulations in the digital health space. The announcement comes close after the 21st Century Cures Act which, among several proposals, starts to outline the role of FDA in overseeing digital health.It further clarified its plans with regard to regulation of digital health technologies in a new blog post last July. The most notable announcement was the new Pre-Cert for Software Pilot Program.The pre-cert program has important inclusion criteria that limit participants to those developing a “software product that meets the definition of a medical... Read More

  • Digitization of Healthcare

    Digitization of Healthcare

    Scientific and technological innovation are at the heart of improving the way doctors treat illness and disease. Long defined by non-interoperable systems and inaccessible data, digitization of healthcare now elevates and innovates data usage and analytics  — which benefits patients, physicians, and hospitals.When it comes to digitization, the healthcare industry is slowly moving forward, across a highly regulated field dealing with massive amounts of sensitive information about patients.One of the most notable efforts in this area has been the more than decade-long push to adopt electronic health records, the digital version of each... Read More