Industry Watch – Nov/Dec 2018

Researchers from University of California San Diego School of Medicine, with statewide collaborators, report that patients who recorded videos of themselves taking tuberculosis (TB) medications better adhered to treatment than patients who were observed in-person.

The study also found that using a smartphone, called video directly observed therapy (VDOT), cost less and was preferred over in-person directly observed therapy (DOT). Study results appear in the October print edition of Emerging Infectious Diseases.

“Prior studies showed that VDOT worked well in urban areas with large TB control programs. This time we wanted to know if VDOT would be as effective in monitoring TB in rural counties with smaller health departments,” said first author Richard Garfein, Ph.D., MPH, professor in the Division of Epidemiology, part of UC San Diego School of Medicine.

The study took place in California, which reports the highest number of TB cases in the United States. Garfein and his team found that VDOT results were similar across five diverse counties. He said this is promising news for health departments in the U.S. that manage too few TB cases annually to justify designating staff exclusively to TB response. San Diego was the first county in the U.S. to employ VDOT using recorded videos.

TB is the world’s leading cause of death from an infectious disease. The condition is treatable, but therapy typically takes six months. Patients must take approximately 12 antibiotic pills per day to cure the disease, avoid transmission and prevent antibiotic resistance. Drug-resistant TB can require up to two years to treat.

Since medication side effects can make patients feel sick, even after their TB symptoms subside, the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) recommend watching patients swallow every dose of medication using DOT to ensure they complete their treatment. VDOT is a new way for health workers to monitor medication adherence and support patients who struggle with treatment.

With VDOT, patients used a smartphone and a HIPAA compliant application to record the administration of each medication dose and send videos to their medical provider. Study participants who used VDOT had 93% of their medication doses observed on schedule compared with 66% among patients who used DOT. The study involved 274 participants who used VDOT for a median period of 5.4 months. Overall, patients’ ages ranged from 18 to 87 years. Sixty-one percent were male; 72% owned a smartphone. University of California San Diego School of Medicine

APPS

Fertility apps are increasingly being used as contraception, and one has even gained FDA approval

The Food and Drug Administration recently approved mobile fertility app Natural Cycles as a method of contraception. While Natural Cycles was certified in Europe last year, this is the first time the U.S. has allowed a mobile app to advertise itself as a medical device that prevents pregnancy.

In doing so, the FDA created a new category for birth control called “software application for contraception.”

Natural Cycles uses its own basal body thermometer and algorithm to calculate when a woman is fertile or infertile. It requires that users log their menstrual cycles and take their temperature at the same time every morning, before getting out of bed.

Drawing on clinical studies involving 15,570 women, the FDA states that the app’s efficacy rate is 93.5% for typical use and 98.2% for perfect use.

In January, the app came under fire when a Stockholm hospital reported that 37 women seeking abortions were using Natural Cycles as birth control. But the Swedish Medical Products Agency concluded in September that the unwanted pregnancies were inline with typical use failure rates.

Still, the discipline involved with the daily tracking of one’s cycle and temperature has some doctors concerned.

After all, while using an algorithm may make Natural Cycles seem high-tech, the premise behind the app is nearly a century old. Birth control methods based on tracking ovulation are called fertility-awareness methods, and they’ve been around since the 1930s. According to the Centers for Disease Control and Prevention, these methods are only 76% effective. The most well-known is the rhythm method, in which women count the days in their menstruation cycle to predict fertility. When women combine counting days with tracking other signs, like temperature or cervical fluid appearance, clinical trials demonstrate much higher efficacy rates.

Doctors and researchers have been eager to see more randomized control trials of the app. And some have criticized past studies of Natural Cycles for being run by the company’s founders and advisory board members instead of neutral parties.

Yet experts expect the prevalence of app-based family planning will continue to rise. Whether women are using fertility-awareness methods for religious reasons or to avoid hormones or implants, there are already nearly 100 apps designed to track menstrual cycles. Glow, Kindara, Daysy and Groove already offer fertility tracking options for women seeking to avoid pregnancy.

The door is now open for these apps to seek FDA approval and even promote themselves as contraception. Natural Cycles

REVENUE CYCLE

TransUnion expands healthcare solutions with agreement to acquire Rubixis

TransUnion announced an agreement to acquire Rubixis, a healthcare revenue cycle solutions company that helps providers maximize reimbursement from insurance payers. Rubixis brings specialized knowledge in the management of denials and underpayments, two significant pain points for healthcare providers.

The healthcare industry continues to struggle with claims denial write-offs, which have climbed consistently over the past decade. Denial write-off adjustments average 3 to 4% of net revenue, which equates to $262 billion in initially denied claims for healthcare providers annually.

Rubixis helps healthcare providers prevent these losses with the goal of collecting the correct amount due from payers as quickly as possible and at the lowest cost. By offering a software platform that leverages analytics, workflow tools, and/or complementary accounts receivable outsourcing services, Rubixis helps healthcare providers collect reimbursement effectively and efficiently.

TransUnion Healthcare’s Revenue Protection solutions help hospitals prevent revenue leakage by engaging patients early, ensuring that their earned revenue gets paid, and optimizing their collection strategies. TransUnion

PRIVACY AND SECURITY

New HITRUST program to help start-ups with information privacy and security

HITRUST is helping start-up companies make information privacy and security a foundational component while still focusing on growing their business with the introduction of the RightStart Program. The new program helps start-ups accelerate their adoption of the most comprehensive risk management, compliance, privacy, and security suite of services in the marketplace.

As a security and privacy standards development and accreditation organization, HITRUST is bundling and pricing its programs to align with rapidly-growing small businesses ensuring management and customers that effective information privacy and security programs are a core tenet of the start-up firm’s operations.

Meeting these requirements should not be a barrier to business growth but too often start-up companies try to institute the proper programs in an ad hoc manner only to lose valuable time and money and in the end, not improving their risk posture.

Designed for start-ups that have been in business for less than three years, have fewer than 50 employees, and have less than $10 million in annual revenue, the program offers a comprehensive risk management solution. The Right Start Program streamlines the adoption of HITRUST’s best-in-class suite of services, including:

• The HITRUST CSF allows organizations to perform assessments and report against its comprehensive privacy and security controls or any one of the 35 authoritative sources included in the framework, such as the NIST Cybersecurity Framework, HIPAA, and GDPR.
• The HITRUST CSF Assurance Program provides a simplified and consistent approach to assessments and reporting against the HITRUST CSF. Since the HITRUST CSF synthesizes numerous standards and frameworks into a single comprehensive and harmonized framework, it negates the need for multiple assessments with an ‘Assess Once, Report Many’ approach.
• The HITRUST MyCSF Assessment Platform makes it easier and more cost-effective for an organization to manage information risk and meet international, federal, and state regulations concerning privacy and security.
• The HITRUST Academy offers the only training courses designed to educate security professionals about information protection and the utilization of the HITRUST CSF to manage risk. HITRUST