Showing all posts written by Scott Seeley

Scott Seeley
Scott Seeley
Scott Seeley is an associate in our Seattle office.
Scott Seeley earned his J.D from the university of Washington School of Law. During his time in Law School, Scott externed for the United States District Court for the Eastern District of Washington Yakima.
Before Law School, Scott attended Central Washington University where he earned his B.S. in Chemistry with a specialization in Biochemistry.
Scott was a Summer Associate in 2014, and joined the firm as an Associate in 2015.

Apple Releases Electronic Health Record Aggregation Tool in iOS 11.3

According to an Apple press release, iPhone users will now be able to store and view their medical records on their phones as part of a new feature found in iOS 11.3.  Although many patients are already familiar with clinic-specific patient portals, Apple’s new Health Records feature is said to allow patients to download their medical records from a variety of hospitals and clinics, and consolidate those records on their iPhone.

According to Apple, the Health Records feature can be found in Apple’s Health app on updated devices.  The Health Records feature allows participating hospitals and clinics to transfer medical information to a users device. The patient’s medical record data will be stored along with their own patient-generated data in the consolidated Health app.  Users will be able to view recorded allergies, clinical vitals, conditions, immunizations, lab results, medications, procedures, and similar information.  Users will also be notified whenever their data is updated, such as when lab results are received.

Apple notes that in the past, patients’ medical records were held in multiple locations, requiring patients to log into each care provider’s website and piece together the information manually.

The press release notes that data within the Health Records feature will be encrypted and protected with the user’s iPhone passcode.  Moreover, no health record data passes through Apple’s network.  Instead, Apple relies on Fast Healthcare Interchangeability Resources (FHIR) and related application programming interfaces (APIs) to transmit the data from a hospital or clinic’s electronic health record (EHR) system directly to a user’s device over an encrypted connection.

As a result, Apple maintains that it does not create, transmit, or receive any protected health information for or on behalf of a covered entity or business associate.  Nevertheless, if a user chooses to sync their health data with iCloud, the data will be encrypted in transit and for storage on Apple’s servers.

With the push to provide patients with their digital health information comes a push for FHIR, solidifying the technology’s viability as a solution to the federal mandate that providers allow patients to access electronic versions of their health records

Apple notes that at this time, around 40 hospitals and clinics are participating, including Johns Hopkins, Cedars-Sinai, Penn Medicine, UC San Diego Health, and Geisinger Health System.

 

 

 

 

 

 

First-Ever De Novo Clearance by FDA’s Orthopedic Branch

According to IlluminOss Medical, Inc.’s recent press release, the company has successfully obtained the first-ever de novo clearance from the FDA’s Orthopedic Branch for its minimally invasive bone stabilizaion system (the “IlluminOss System”).  According to the FDA, the de novo clearance is reserved for new, novel devices whose type has not been previously classified.

IlluminOss, a privately held commercial-stage medical device company based in East Providence, Rhode Island, describes itself as being involved in the development and commercialization of minimally invasive fracture fixation techniques.  The company explains that the newly-approved IlluminOss Bone Stabilization System is used for the treatment of impending and actual pathological fractures of the humerus, radius, and ulna resulting from metastatic bone disease.

Traditional bone stabilization procedures utilizing invasive techniques and intramedullary rods can risk causing extensive soft tissue damage and reduced patient mobility.  Moreover, the metal plates and rods may increase patients’ risk of cortical porosis, delayed bridging, and refractures upon removal.  Regarding its IlluminOss System, IlluminOss states:

The IlluminOss System was developed with an aim to provide improved patient experiences and outcomes when treating pathologic fractures. There is a critical need to make less invasive orthopedic fracture repair options available to an aging and underserved market segment.

In contrast to traditional fixation techniques, the IlluminOss explains that its System uses a small-diameter PET balloon and visible light fiber, each of which may be threaded through a 4.5 mm pathway into the medullary canal through a small incision in the patient’s skin.  Once inserted, the PET balloon is filled with a photoactive liquid monomer, causing the balloon to expand and conform to the specific shape of the patient’s bone.  With the liquid-filled balloon in place, the photoactive monomer is polymerized utilizing the visible light fiber, resulting in a hardened implant which conforms to the patient’s specific bone structure within 90 seconds.  The hardened implant stabilizes the fracture by providing both longitudinal and rotational stability across the length of the implant.

The IlluminOss System has been available internationally since 2010.  IlluminOss reports success in international markets: surgeons have reported smaller incisions, shorter procedure times, and a faster return to the patient’s daily living activities.  Reduced complication rates, and shorter hospital stays have also been observed.

With marketing clearance in hand, IlluminOss plans to initiate U.S. commercialization efforts in the second quarter of 2018.