All posts by David Sclar

CMS Announces Certain Updates for 2014 Open Payments Data Collection

The Centers for Medicare and Medicaid Services (CMS) recently announced certain updates for the 2014 Open Payments data collection period.  These updates include: Publication of a 2014 teaching hospital list Establishment of 2014 de minimis reporting thresholds Clarification of 2014 submission file specifications Parties affected by the Open Payments program can […]

HIPAA Breach at Iowa Hospital Chain Highlights the Vulnerability of Electronic Medical Records and the Importance of Internal Audits

Another month, another HIPAA breach.  On October 2, 2013, UnityPoint Health, a large network of hospitals and clinics in Iowa and Illinois, announced that it had discovered a breach of its electronic medical records system and alerted the FBI.  The breach, in which a contractor gained access to the system over the course of […]

Available Now: FDA’s Final Guidance on Wireless Medical Devices

While the FDA has yet to issue final guidance on mobile medical applications, the FDA recently issued final guidance on radio frequency (“RF”) wireless technology in medical devices (“wireless medical devices”). For comparison, the anticipated guidance on mobile medical applications is expected to address questions such as, “Will/How will mobile medical […]

Mobile Health Apps Implicate Data Privacy and Security Laws

Privacy concerns regarding mobile devices in health care are raising eyebrows and making headlines. The Telegraph reports that “health and fitness apps have been harvesting sensitive personal data and passing it on to insurance and pharmaceutical companies” although “apps companies . . . have denied that the information is personally […]

Sunshine Act Brochures Provide Highlights for Patients and Physicians

The National Physician Payment Transparency Program, also known as Open Payments, affects many health care industry participants.  Accordingly, even though applicable manufacturers and applicable group purchasing organizations (GPOs) are the only entities required to report data under the program, the Centers for Medicare & Medicaid Services (CMS) is not overlooking patients […]

September 23, 2013: What It Means for HIPAA Business Associate Agreements

September 23, 2013 is rapidly approaching, and Covered Entities and Business Associates must comply with the requirements of the HIPAA Omnibus Rule by this date. Among the tasks facing Covered Entities and Business Associates seeking to meet Omnibus Rule requirements, they must ensure that their Business Associate Agreements (“BAAs”) comply […]

CMS Publishes FAQs for OPEN PAYMENTS Mobile Apps for Physicians & Industry

As we noted last week, CMS released two mobile apps for tracking reportable payments: one for physicians and one for applicable manufacturers and applicable GPOs. Both are available for download now for iOS (Apple™) and Android™ mobile phones.  New FAQs from CMS provide additional visibility into how CMS envisions physicians and industry using these […]