At-home diagnostic tools give medical device manufactures a new way to connect with consumers

Health Care Current | September 25, 2018

This weekly series explores breaking news and developments in the US health care industry, examines key issues facing life sciences and health care companies, and provides updates and insights on policy, regulatory, and legislative changes.

My Take

At-home diagnostic tools give medical-device manufactures a new way to connect with consumers

By Greg Reh, vice chairman, US and Global Life Sciences leader, Deloitte LLP

One of the earliest known at-home diagnostic tests dates back to Egypt in about 1350 BCE. It was a pregnancy test that relied on wheat and barley seeds, rather than a plastic stick, to make a diagnosis. In the early 1960s, researchers determined this ancient test would have been accurate about 70 percent of the time.1

Fast forward 3,300 years to today as we head to AdvaMed’s annual medtech conference where the latest at-home diagnostics will certainly be a topic of conversation. We have entered an era where everything from a person’s ancestry to his or her complete microbiome can be deciphered from the genetic information contained on a cotton swab or in a drop of blood. A growing awareness about the health benefits of preventive care and early diagnosis is helping fuel demand for at-home diagnostic tools that can detect an array of illnesses and conditions. According to the Food and Drug Administration’s (FDA) website, home tests can be cost-effective, quick, and confidential. But the agency notes that such tests should not replace periodic visits to the doctor.

Consumers are becoming comfortable with DIY medical tests
Consumers are increasingly open to new channels of care—particularly at-home diagnostic testing, according to the results of our new survey of health care consumers. About half of this year’s survey respondents said they are comfortable using an at-home test to diagnose infections (e.g., strep throat and urinary tract infections) before going to the doctor for treatment. Nearly as many—45 percent—said they would consider an at-home genetic test to identify existing or future health risks, and 44 percent are comfortable using an at-home blood test that connects to an app to track overall health trends, such as cholesterol, blood glucose, inflammation, and triglycerides. We also found that the number of consumers who use wearables to track their health data has more than doubled since 2013—and consumers have become more comfortable with sharing their data. Forty percent of health care consumers said they would share their health data with a device manufacturer if it helped improve the device.

Five conditions consumers could test at home
As at-home diagnostic testing becomes more accepted, medical-device manufacturers might have an opportunity to strengthen the relationship they have with consumers and their physicians. Increasingly sophisticated tools have the potential to improve health outcomes through faster diagnoses, 24/7 access to health coaching, and the ability to recognize mood and lifestyle changes that could affect adherence to a treatment plan. Moreover, DIY diagnostic tests could help low-income or rural consumers determine if a condition warrants a visit to a doctor or hospital.

Many device manufacturers are developing tools, tests, and apps along a continuum of wellness and prevention—ranging from acute diagnosis and chronic-disease management to identifying future risks of illness. Here’s a look at some areas where device manufacturers are innovating:

  • Cancer: Last March, the FDA approved the first at-home diagnostic test that can detect three specific BRCA1/BRCA2 breast cancer gene mutations that are most common among Jewish people of Eastern European descent. The test was developed by the genomics and biotechnology firm 23andMe. In a press release, FDA noted that the test only detects three out of more than 1,000 known BRCA mutations. A year earlier, the agency gave the company permission to market its Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. DNA is collected on a cotton swab, which is swiped inside the consumer’s mouth, and mailed to the company for analysis.2
  • Influenza: The Biomedical Advanced Research and Development Authority, a division of the US Department of Health and Human Services (HHS), recently announced that it is investing $24 million with two companies that are developing at-home flu tests. Cue Health will receive $14 million to develop a flu test that will be included in its in-home health monitoring technology platform. Diassess will receive $10 million to develop a single-use test (see the July 24, 2018 Health Care Current). With an at-home flu test, patients could use an app or device to send information to their physicians, who could then prescribe medication that can be delivered to the patient’s door. Patients would not have to leave their homes, which could help reduce the spread of the illness.
  • Electrodariograms (EKGs): During a September 12 event, Apple, Inc. announced its latest Apple Watch®* would include a EKG sensor that can alert the wearer to irregular rhythms.3 Another company, AliveCor, has developed a remote monitoring device for arrhythmia (Kardia) that plugs into a smartphone and can conduct an EKG in 30 seconds.4 The user puts his or her finger on the device, which then transmits a reading directly to a physician. The physician can then track patterns and diagnose symptoms.
  • Heart health: Cor5 measures heart health using a sample of blood and a connected app. The blood test measures cholesterol, fasting blood glucose, inflammation, and triglycerides. The app then provides insights based on trends and patterns in these indicators. It also provides diet, exercise, supplement, and relaxation recommendations.
  • Microbiome health: Several companies—including Day Two Inc,6 uBiome Inc.,7 and Viome Inc.8—offer direct-to-consumer microbiome analysis. These tests provide personalized nutrition and behavioral recommendations tailored to the individual’s microbiome composition (i.e., the genetic material of the microorganisms that live in the gut). Some tests provide information about microorganisms associated with specific infections and metabolic disorders.

In ancient Egypt, physicians diagnosed their patients and recommended treatments based on observable symptoms. This level of care, however, was generally reserved for royalty and the wealthy. Today, many medical device manufacturers are developing a wide range of low-cost tools that allow anyone to assess their overall health status, or to identify a growing number of existing or potential illnesses. As these devices become more prevalent, clinicians should determine how to decode the information from these new data streams and use it to improve diagnoses, care, and outcomes. Partnerships between medical device manufactures (including EHR vendors) and providers could potentially help this effort.

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* Apple Watch® is a trademark of Apple Inc., registered in the U.S. and other countries.

1 National Institutes of Health, a Timeline of Pregnancy Testing.
2 FDA press release, March 6, 2018 (


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In the News

Senate HELP holds hearing on health care costs, price transparency

On September 18, the Senate Committee on Health, Education, Labor & Pensions (HELP) held a full-committee hearing on reducing health care costs. The hearing focused on how the government can reduce costs and whether greater price transparency could reduce health care spending.

Witnesses agreed that consumers need better data on health care prices, out-of-pocket costs, and care quality. Ty Tippets, administrator of St. George Surgical Center, told lawmakers that about 80 percent of his organization’s patients want information about the price of medical services, but only about 25 percent of them ask. A few witnesses noted that transparency is not a stand-alone solution to improve the health care system.

On the same day, members of the bipartisan Senate Working Group on Health Care Price Transparency released draft legislation to protect patients from surprise medical bills, calling the legislation a key step toward transparency.

The Senate HELP committee will hold another hearing on reducing health care costs and improving affordability through innovation on September 27.

CMS proposes to lift regulations, ease provider burden

On September 17, the US Centers for Medicare and Medicaid Services (CMS) released a proposed rule to remove some of the requirements that health care facilities must meet to participate in Medicare. The agency estimates that policies from this proposed rule could save hospitals and other facilities $1.12 billion annually, according to a press release.

CMS’s proposed rule would make it easier for facilities to meet the health and safety standards for participation. A key provision would eliminate a requirement that transplant programs resubmit clinical experience, outcomes, and other data more than once for Medicare approval. According to CMS, this “re-approval” process has discouraged programs from performing transplants for certain patients—and caused some organs to go unused. The agency would maintain other requirements to ensure quality and would monitor outcomes after initial Medicare approval.

Other provisions in the proposed rule include:

  • Streamlining hospital and ambulatory surgical center (ASC) requirements for conducting comprehensive patient medical histories and physical assessments.
  • Allowing health systems to unify and integrate Quality Assessment and Performance Improvement programs for all member hospitals.
  • Simplifying the process for ordering portable X-rays and modernizing the personnel requirements for technicians.
  • Removing duplicative ownership-disclosure requirements for Critical Access Hospitals.

This proposed rule is one of several steps CMS has taken to reduce the administrative burden for hospitals. Since CMS first launched its Patients Over Paperwork initiative in 2017, the agency has made several efforts to address regulatory relief, including holding stakeholder interviews and leading a robust request-for-information process. According to the agency, its stakeholder-engagement efforts yielded 3,040 mentions of the word “burden.” So far, CMS says it has addressed 624 of the burden topics raised. By 2021, CMS projects all final rules issued in 2017 and 2018—along with its proposed rules—will generate nearly $5.2 billion in savings over five years and will reduce reporting hours by 53 million.

(Source: CMS, CMS Proposes to Lift Unnecessary Regulations and Ease Burden on Providers, September 17, 2018)

Report: AI could save health care $150B by 2025

The adoption of artificial intelligence (AI) and cognitive computing in health care could generate more than $150 billion in savings by 2025, according to a new report from market research firm Frost & Sullivan. The real-world benefits of AI-enabled solutions, according to the report, include treatment personalization, automated disease prediction, and intuitive claims management. Between 15 and 20 percent of end-users have AI capabilities to drive change in health care delivery, the report estimates. AI-enabled digital assistants have also become popular tools for people who want to track their health and fitness, according to the results of Deloitte’s recent survey of health care consumers.

Frost & Sullivan projects that AI adoption will grow significantly, partially due to large IT companies offering cost-effective infrastructure to support vendors. The report anticipates the global health care AI market will reach $6.16 billion by 2022—a compounded annual growth rate of 68.5 percent. Additionally, the report referred to the US as the “global hub” of health care AI due to its strong performance across seven of Frost & Sullivan’s AI maturity metrics: investment, incubator, infrastructure, patent, talent, global collaboration, and end-user adoption.

(Source: Frost & Sullivan, Artificial Intelligence in Healthcare Takes Precision Medicine to the Next Level, September 13, 2018)

Senate passes $854B spending bill

On September 18, the Senate voted 93-7 to pass a $854 billion spending bill that includes funding for the US Departments of Defense (DOD), HHS, Labor (DOL), and Education (DOE). Included in the bill’s provisions are defense research, military pay increases, Pell Grant increases, funding for the National Institutes of Health (NIH), and workforce-development training. The bill also contains a Continuing Resolution (CR) to extend government funding through December 7.

Last week, the House approved a three-bill appropriations “minibus” spending package for submission to the White House for approval, and the House Appropriations Committee filed a two-bill “minibus” package to fund various health care initiatives (see the September 18, 2018 Health Care Current).

Senate passes major bipartisan opioids package

On September 17, the Senate passed a package of 70 bills aimed at addressing the country’s opioid crisis. The package, which has strong bipartisan support, is expected to cost $8.4 billion. Specific provisions include:

  • Stopping illegal fentanyl (synthetic opioids) from entering the country, especially from China. The bill would close loopholes that allow people to sneak fentanyl into the country through the mail. The bill would also require that foreign packages reveal their contents and indicate who is sending it and where it originated.
  • Supporting people who are in treatment or recovery. The legislation authorizes a grant program through the Substance Abuse and Mental Health Services Administration (SAMHSA) that would allow organizations to develop opioid recovery centers in a community. It requires HHS to determine best practices and create a grant program implementing those policies or procedures, such as recovery coaches. It also authorizes HHS to develop grants to support people who are in recovery and transitioning to independent living and jobs—the agency would develop a pilot program to provide temporary housing for people in recovery.
  • Loosening some guidelines around medication-assisted treatment. The legislation would lift the cap on the number of patients to whom a qualified doctor can prescribe drugs such as buprenorphine. It also expands a grant program allowing first responders to administer medication-assisted treatments.

The House passed a similar measure in June and the two chambers will need to negotiate a few differences before sending the package to the president’s desk. The two chambers are debating multiple provisions, including 1) whether to loosen restrictions to make it easier for health providers and clinicians to share behavioral-health information, and 2) whether to get rid of the Medicaid Institutions for Mental Diseases exclusion, a decades-old rule prohibiting Medicaid from paying for the treatment of patients with severe mental illness in most inpatient treatment centers.

Breaking Boundaries

These startups recognize the power of voice-enabled technology for health care

Several startups are looking ahead to converging trends in health care and are working on ways to harness the power of voice-enabled technology for patients and consumers. Aging in place, enhancing patient-doctor communications, reducing a physician’s administrative burden, detecting vocal biomarkers, and increasing patient engagements are among the trends driving investments in voice-enabled technology.

Research has shown that seniors are interested in aging in place (i.e., remaining in their homes as long as possible). Digital assistants that use voice technology do not require mobility, hand dexterity, or good vision. Cuida Health offers LISA, (Learning Interface for Senior Adults). LISA can urge seniors to exercise, provide reminders about appointments, and notify them when it’s time to take their medication. The voice assistant can check in with the patient about sleep and eating habits, and can send and receive messages from friends, family members, and caregivers.

Other companies are exploring ways to reduce the administrative burden on physicians and care teams. Syllable’s chatbot can answer common questions from patients and can facilitate physician referrals, collect health-risk assessment and pre-screening data from patients, and automate scheduling.

A company called has a virtual assistant named Sarah that can function as a receptionist for busy practices. AI powers Sarah’s speech-recognition capabilities and her medical training. She does not offer medical advice, but is trained to listen to patient concerns. This information can be put into context to better triage the patient. Sarah also can schedule patient appointments, send reminders, make follow-up calls, and answer simple inquiries.

Kiroku offers technology that can listen to conversations between dentists and patients and then generate clinical notes. Dentists spend up to 25 percent of their day taking notes, according to the company.

Several companies are developing technologies that can measure biomarkers based on a patient’s vocal patterns. Biomarkers, which are typically measured via blood tests, are indicators of disease, infection, or environmental exposure. But vocal patterns such as pitch, tone, rhythm, volume, and rate are increasingly being used as vocal biomarkers. This data can help care teams identify a range of conditions from cognitive disorders to heart attacks. A number of companies—including BeyondVerbal and Corti—are developing technologies that can extract various features from a person’s voice and provide insight into their health conditions and overall wellbeing. A company called WinterLight Labs is using AI to use speech patterns to detect and monitor cognitive and mental diseases.

Analysis: Innovation is alive and well in health care and consumers are interested. Findings from Deloitte’s 2018 Survey of US Health Care Consumers shows that digital and voice assistants, which are commonly found in the home, are popular among people who are interested in tracking their health. About 75 percent of consumers who use technology for health care purposes rely on digital assistants for reminders or alerts about medication, while 72 percent of this group use digital assistants to monitor health.

(Source: John Brownstein, Jennifer Lannon, and Sarah Lindenauer, 37 Startups building voice applications for healthcare, mobi health news, August 3, 2018)

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