Compliance Corner – News Round Up

August 30th, 2017 by Sharon L Nelson, MSN, RN, CNS, CIP, Executive Director, Consulting and Compliance Services

provision logoIn the US, we often treat this time of year as “back to work” time. Whether you’re returning to a new academic year or just returning to work after the lovely distractions of summer, this is a season of organization and preparation. With that in mind, we’ve put together some helpful lists related to current events to help you ease into Autumn.



As health care consumers and as human research professionals, we are familiar with HIPAA Authorizations for use and disclosure of protected health information, and we understand the patient’s right to access medical records that are used to make decisions about individuals. It’s like having the right textbooks at hand to study for a test. But do we understand what happens when an individual seeks access to his/her own health data? How do we each obtain our own health textbooks?

In Many Lessons Still Need to be Learned regarding Patient Access to Health Care Information, Ryan Marcus and Lisa Mazur discuss research findings in a recently released Report by The Office of the National Coordinator for Health Information Technology. The research examined the user experience of 17 individuals seeking patient access to health data and processes of 50 health systems, with the objective to define medical record request process improvement for consumers. The results? “Patients and health care providers alike need a well-defined process that is convenient, expedient and transparent.”

The four main issues hindering the patient record request from being convenient are:

  1. Complete and accurate records

Patient records are often incomplete or contain mistakes, leaving both patient and provider with less than full understanding of the patient’s health status. Fragmented physical storage complicates accessibility of complete information.

2. Online records management

Patient records are still largely paper-based, and patients are often forced to pick up physical copies of information. Where online patient access portals are available, they are also confusing and may exclude some segments of the population.

3. Portable records

Without a single portal to all relevant records across all providers, assembly of a complete and consolidated record is challenging, especially when a patient requests his or her records at the last minute.

4. Transparency in the records request process

When patients request their records, there is often a lack of communication following submission of a request: there may be no confirmation of receipt of the request or indication of when they will receive the records. Naturally, stress ensues.

Read here to learn more about the Report and its suggestions for process improvement. Studies have shown that better informed patients can make better healthcare decisions, but it appears we first need to find better ways to get the information to the patients.



Next, a geography quiz: How do the regulatory requirements, structure and processes of regulatory authorities differ across the globe?   In New Research Compares Drug Regulators Around the Globe, Zachary Brennan of Regulatory Affairs Professionals Society (RAPS) highlights some of these differences in a recently published study examining data on new drug application (NDA) submissions and approvals for 2015 and 2016.

Among the findings:

  • Number of technical reviewers:
    • US FDA has the most internal reviewers – 2000.
    • The EMA works with a pool of 4500 scientific experts from member countries
  • Number of new drug approvals
    • FDA held the record in 2015 with 45.
    • Japan’s 48 approvals in 2016 set the new record.
  • Standard Review Timelines (in days)
    • For the fastest review, EMA ties with the UK’s MHRA and Russia’s Roszdravnadzor at 210 days.
    • FDA’s standard timeline is just a few months shy of a year at 300 days.
    • At 900 days, China’s FDA standard review timeline stretches longer than any other country included in the review.
  • NDA review fees (in USD)
    • The US FDA leads the pack with fees per NDA estimated at $2.3 million.
    • India’s fees seem like a comparative bargain at approximately $1000.

To learn more about the data collection, analyses and findings, explore here and here.



It’s not a pop quiz, but still, a quick refresher never hurts this time of year: Test your fund of knowledge and enjoy MedScape’s list of 12 Key Accidental Discoveries in Medicine, featuring the serendipitous origin of some of medical science’s advancements.