FDA and IBM Watson Health Collaborate on Blockchain for Health Data: Eight Approved Digital Health Projects Highlight 2017 Q1 Innovations

The first quarter of 2017 has passed, and we have compiled a list of eight FDA-approved projects. Although the list is not extensive, it showcases the diversity and novelty we seek—ranging from applications for diabetes treatment to device integration, and even vests that can reflect our heart rhythms.

Additionally, several significant changes occurred at the beginning of this year.The Trump Administration Has Officially Nominated Dr. Scott Gottlieb, Who Has Extensive Medical and Venture Capital Backgrounds, as Deputy Commissioner of the FDAGottlieb made it clear that he believes the regulation of mobile health should adopt exceptionally strict measures, rather than following general rules.

Dr. Scott Gottlieb, with extensive backgrounds in healthcare and venture capital

Regarding the solution,Gottlieb Advocates Reducing the Role of Digital Health Tools at the FDA, and then passed on to these newly established government groups or industry self-regulatory organizations. This is a solution that can sometimes be controversial, but Gottlieb believes that this is exactly what EHRs need to do at such a politically prioritized time, while those in power at HHS also do not want their hands tied by FDA regulations.

The FDA itself is also reexamining its role during these periods of evolving policies., while the FDA announced that it is considering establishing a dedicated Office of Patient Affairs,The office will prioritize soliciting patient perspectives., and then comprehensively consider these insights to formulate relevant regulatory policies.

A typical example is the Medical Device User Fee Amendments (MDUFA), an agreement between the FDA and industry whereby the FDA agrees to certain commitments in exchange for user fees paid by companies for the regulatory review of their devices. The FDA has been working to reorganize and centralize its digital health operations.

Jeffrey Shuren, Director of the FDA’s Center for Devices and Radiological Health, stated: “A key component of the MDUFA 4 reauthorization will be the establishment of a Digital Health Center within the agency to promote coordination and consistency across divisions. We have implemented a tiered reviewer structure. The first tier consists of ‘Yellow Belt’ reviewers, who treat such software as conventional medical devices and receive only basic training. The second tier comprises ‘Green Belt’ reviewers, who address more common issues. Within the office, we will also cultivate specialized ‘Black Belt’ experts capable of understanding diverse digital health units and engaging in more challenging reviews, thereby ensuring consistency in device evaluations.”

Shuren first shared some highlights that the agency was able to achieve under MDUFA 3.

“We need to make changes to both our culture and policies. In fact, the number of innovative devices we have approved has nearly doubled, rising from 24 in 2009 to 92 in 2016—the highest record since the user fee program was launched in 2003.”

Shuren did not mention the companies involved, but he emphasized the FDA’s efforts on behalf of Dexcom G5, stating that it was the FDA that helped the company bring its technology to market.Changing the Agency’s Approach to Digital Health: The FDA Continues to Engage with the International Medical Device Regulators Forum and Make Ongoing Efforts。

Shuren stated, “Part of this agreement involves continuing international harmonization efforts within the IMDRF. In addition to digital health materials, he discussed other provisions of the amendments, including increased emphasis on patient engagement and feedback, as well as the continued use of real-world evidence in device approval and reintroduction to the market. Much of the FDA’s work on real-world evidence is carried out through an initiative known as the National Evaluation System for Health Technology (NEST).”

“One shortcoming of our current healthcare system is that we collect information from diverse patient scenarios every other day but fail to leverage it effectively. First, the data may be non-standardized, incomplete, or of poor quality. Moreover, these data are scattered across electronic health records (EHRs) and payer claims. Therefore, the key lies in harnessing market forces and leveraging the collective purchasing power of the ecosystem to drive greater standardization and consistency, reduce the time and cost associated with utilizing this information, and ultimately employ these insights for decision-making.”

Shuren did address the question of what would happen to the FDA if MDUFA failed to pass for any reason.

He stated, “If we fail to reauthorize MDUFA 4, we will immediately lose one-third of our workforce, and we will subsequently face further adverse consequences, such as being unable to uphold our current MDUFA commitments.”

To expedite the implementation of new FDA functionalities, the FDA announced a collaboration with IBM Watson Health.These two organizations will study how to use blockchain technology to share health data, with the ultimate goal of improving public health.The initial two-year collaboration will focus on the analysis of oncology data, including the aggregation and exchange of data from various sources such as clinical trials and genomics, as well as Internet of Things (IoT) data from electronic medical records (EMRs), wearable devices, applications, and connected devices.

Below are eight representative companies that received FDA approval from 2017 up to the date of publication:

1. Medtronic received FDA 510(k) clearance for its sensor-based vest.

This vest is a single-use, disposable wearable product known in the industry as the CardioInsight Non-Invasive 3D Mapping System. The vest is equipped with 252 electrode sensors that provide comprehensive bi-atrial and bi-ventricular electroanatomic 3D maps of the heart. It pairs body-surface electrocardiogram (ECG) signals acquired from the thorax with data derived from cardiac computed tomography (CT) scans, and then integrates them via the CardioInsight Workstation. Available in four sizes, the vest is designed to conform to the wearer’s body contour, enabling continuous panoramic mapping of both atria or both ventricles when catheter-based approaches are not feasible.

2. The compact, portable continuous positive airway pressure (CPAP) device AirMini received FDA 510(k) clearance

ResMed’s new device, AirMini, based in San Diego, California, is designed primarily as a supplementary option—particularly useful when traveling or at any other time when users cannot access or prefer not to carry full-sized CPAP equipment. AirMini is scheduled for launch later this year and is not yet commercially available; however, its compact size, comparable to that of a standard pair of sunglasses, speaks volumes about its portability and convenience.

3. WellDoc’s Mobile Diabetes Management Platform BlueStar (Over-the-Counter Version) Receives Green Light

Having received 510(k) Class II clearance, WellDoc can offer both BlueStar and BlueStar Rx simultaneously. This enables the company to analyze patient-entered diabetes data from both versions through multiple channels, compare it with historical patient data to identify trends, and ultimately generate personalized guidance. The software can create strategic data analysis summaries for healthcare teams to support clinicians’ decision-making; however, the over-the-counter version does not include a full insulin requirement calculator.

4. Pharmaceutical company Eli Lilly also received FDA 510(k) clearance

They have newly launched the mobile application Go Dose, a tool for diabetes management and insulin rationing. Similarly, this application comes in two versions: Go Dose, designed specifically for patients, and Go Dose Pro, tailored for healthcare providers.

5. “Cambridge Cognition”’s product, Cantab Mobile, received FDA approval

Cambridge Cognition’s product is an iPad-based assessment tool for memory issues in the elderly. The application, which already bears the CE mark, received FDA clearance on January 13 of this year. CANTAB Mobile is essentially a 10-minute test based on the Paired Associates Learning (PAL) paradigm. It manages data via tablet and includes three distinct exercises that allow users to assess their memory. This product can serve as an early warning system for dementia and Alzheimer’s disease. It is also used in depression screening, enabling differential testing to distinguish between mood disorders and memory impairments.

6. “Fever Scout” Pediatric Peel-Off Continuous Thermometer Receives FDA Approval

VivaLnk, a health technology company based in Santa Clara, has received FDA approval for its first product, the “Fever Scout,” a pediatric peel-and-stick continuous thermometer. VivaLnk had initially announced plans to launch the Fever Scout at CES 2015, but the release was significantly delayed. The FDA’s approval suggests that the device will soon hit the market.

7. Wearable External Defibrillator LifeVest Receives FDA Approval

Last year, the U.S. Food and Drug Administration (FDA) approved Zoll Medical Corporation, a medical device manufacturer, to market its wearable external defibrillator for hospital use. LifeVest is a similar product designed specifically for home use. It systematically monitors the user’s heart rhythm. Upon detecting signs of ventricular tachycardia or ventricular fibrillation, as well as any irregular heart rate activity, the device immediately checks whether the wearer is still conscious. If the wearer remains conscious, the device automatically aborts therapy. If the wearer does not respond within one minute, the system delivers a vibratory alert. If the first shock fails to restore normal heart rhythm, it will promptly deliver subsequent therapeutic shocks.

8. FDA Approves Marketing of 23andMe’s Genetic Tests for Alzheimer’s Disease and Other Conditions

The U.S. Food and Drug Administration (FDA) has approved genetic testing company 23andMe to provide consumers with tests for 10 different conditions. Today, consumers can quickly send saliva samples to the genetic testing company and then obtain data on their risk of developing diseases such as Parkinson’s disease, late-onset Alzheimer’s disease, and celiac disease based on their genetic makeup.

FDA approval will not currently extend to diagnostic tests, such as those used to assess a woman’s risk of breast cancer, because such tests could lead individuals to opt for prophylactic mastectomy of healthy breasts to prevent a disease that may only potentially develop. Naturally, the FDA’s approval of genetic testing remains highly controversial. To date, the FDA has approved tests for ten clinical conditions, including two clotting disorders, Gaucher disease type 1 (an organ disorder), and genetic variants associated with an increased risk of lung and liver diseases.

Source: mobihealthnews/hitconsultant; compiled and edited by VCBeat. This does not represent the views of VCBeat.