Apr 9, 2018 | Laboratory Pathology
Direct-to-consumer (DTC) genetic testing has been much in the news of late and clinical laboratories, anatomic pathology groups, and biomedical researchers have a stake in how the controversy plays out.
While healthcare consumers seem enamored with the idea of investigating their genomic ancestry in growing numbers, the question of how the data is collected, secured, and distributed when and to whom, is under increased scrutiny by federal lawmakers, bioethicists, and research scientists.
However, should public demand for DTC testing find support in Congress, some lab companies offering direct-to-consumer genetic tests could find their primary source of revenue curtailed.
DTC Sales Skyrocket as FDA Authorizes Genetic Tests for Certain Chronic Diseases
Dark Daily reported last fall on one company that had its plans to distribute thousands of free genetic tests at a football game suspended due to privacy concerns. (See, “State and Federal Agencies Throw Yellow Flag Delaying Free Genetic Tests at NFL Games in Baltimore—Are Clinical Laboratories on Notice about Free Testing?” October 13, 2017.)
Nevertheless, consumer demand for DTC tests continues to rise. In a press release, Ancestry, a family genetic history and consumer genomics company, reported:
- Record sales of AncestryDNA kits during the 2017 four-day Black Friday to Cyber Monday weekend, selling more than 1.5 million kits; and,
- The 2017 sales were triple the amount of kits sold during the same period in 2016.
Possibly helping the sale of DTC genetic tests may be the US Food and Drug Administration (FDA) authorization last year of 23andMe’s Personal Genome Service Genetic Health Risk tests for 10 diseases or conditions, including:
Senator Calls for Investigation of DTC Genetic Test Company Use of Patient Data
These are impressive sales. However, medical professionals may wonder how so much genetic data can be kept private by the testing companies. And medical laboratory leaders are not the only ones asking about privacy and the use of genetic test results.
In a November press conference, Senate Minority Leader Chuck Schumer called on the Federal Trade Commission (FTC) to look into genetic testing companies’ privacy and disclosure practices, noted NBC News.
“What those companies can do with all that data—your most sensitive and deepest info, your genetics—is not clear, and in some cases not fair and not right,” stated Schumer.
Congress took action in 2008 by passing the Genetic Information and Nondiscrimination Act (GINA), which bans employers and insurers from making decisions about people based on genetic predispositions to disease.
However, lawmakers also recently introduced House Bill 1313, the Preserving Employee Wellness Programs Act. It reads, in part, “… the collection of information about the manifested disease or disorder of a family member shall not be considered an unlawful acquisition of genetic information with respect to another family as part of a workplace wellness program offered by an employer ….”
“We’re injecting terrible opportunities for discrimination in the workplace,” Robert Green, MD, Professor of Medicine (Genetics) at Harvard Medical School, told Gizmodo.
Robert C. Green, MD, MPH (above), Professor of Medicine, Harvard Medical School; Associate Physician, Brigham and Women’s Hospital; Geneticist, Brigham and Women’s Hospital; and Director, Genomes2People Research Program at Brigham and Women’s Hospital, believes weak genetic privacy laws are inhibiting research and clinical care. “People decline genetic tests because of concerns over privacy and genetic discrimination, especially insurance discrimination,” he told Gizmodo. “This is stymying biomedical research and people’s access to healthcare.” (Photo copyright: Harvard Medical School.)
HIPAA Enables Selling of Anonymized Patient Genetic Data
Peter Pitts, former FDA Associate Commissioner, and President and Co-founder of the Center for Medicine in the Public Interest, a non-profit medical issues research group, blames the release of data by DTC genetic test companies on the Health Insurance Portability and Accountability Act (HIPAA), a law he says makes way for “anonymized” sale of patient data.
“The Portability Act was passed when genetic testing was just a distant dream on the horizon of personalized medicine,” Pitts wrote in a Forbes commentary. “But today that loophole has proven to be a cash cow. 23andMe has sold access to its database to at least 13 outside pharmaceutical firms … AncestryDNA recently announced a lucrative data-sharing partnership with the biotech company Calico.”
For its part, in an online privacy statement, 23andMe noted, “We will use your genetic information or self-reported information and share it with third parties for scientific research purposes only if you sign the appropriate consent document.”
Similarly, Ancestry points out in its posted privacy statement, “We share your genetic information with research partners only when you provide us with your express consent to do so through our informed consent to research.
Consumers Speak Out on Privacy; States Study Laws and Genetic Testing by Research Hospitals
How do consumers feel about the privacy of their genetic test data? According to a news release, a survey by 23andMe found the following:
- 80% of Americans are concerned about DNA testing privacy; however,
- 88% have no awareness or understanding of what testing companies do to protect information; and,
- 74% of people are, nonetheless, interested in genetic testing.
Meanwhile, as states promulgate various genetic privacy laws, a paper published at SSRN by researchers at the Massachusetts Institute of Technology (MIT) and the University of Virginia (UV) examined how different state laws affect patients’ decisions about having genetic testing performed at various research hospitals.
The MIT/UV study focused on genetic testing by research hospitals as opposed to the DTC genetic testing by private companies. The paper explained that states have one of three types of laws to protect patients’ privacy in genetic testing:
- “Require the provider to notify the individual about potential privacy risks;
- “Restrict discriminatory use of genetic data by employers or insurance companies; and,
- “Limit redisclosure without consent.”
Findings, netted from more than 81,000 respondents, suggest:
- When genetic data are explained in state laws as patient property, more tests are performed;
- Conversely, state laws that focus on risk, and ask patients to consent to risk, lead to less people giving the go-ahead for genetic testing.
“We found a positive effect [on the number of tests] was an approach where you gave patients the potential to actually control their own data,” Catherine Tucker, PhD, Distinguished Professor of Management at MIT and one of the study researchers, told MIT News.
Whether the provider of genetic tests is a private testing company or a research hospital’s clinical laboratory, privacy continues to be a concern, not just to physicians but to federal lawmakers as well. Nevertheless, healthcare consumers and patients who receive comprehensible information about how their genetic data may be used seem to be agreeable to it. At least for now, that is.
—Donna Marie Pocius
Related Information:
AncestryDNA Breaks Holiday Sales Record Black Friday to Cyber Monday
Senator Calls for More Scrutiny of Home DNA Test Industry
The Present and Future Asymmetry of Consumer Genetic Testing
Are Our Terrible Genetic Privacy Laws Hurting Science?
The Privacy Delusions of Genetic Testing
National Survey Shows Strong Interest in DNA Testing
Privacy Protection, Personalized Medicine, and Genetic Testing
How Privacy Policies Affect Genetic Testing
State and Federal Agencies Throw Yellow Flag Delaying Free Genetic Tests at NFL Games in Baltimore—Are Clinical Laboratories on Notice about Free Testing?
Apr 6, 2018 | Compliance, Legal, and Malpractice, Digital Pathology, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Management & Operations, News From Dark Daily
Softened FDA regulation of both clinical-decision-support and patient-decision-support software applications could present opportunities for clinical laboratory developers of such tools
Late 2017, the Food and Drug Administration (FDA) released guidelines on how the agency intends to regulate—or not regulate—digital health, clinical-decision-support (CDS), and patient-decision-support (PDS) software applications. The increased/decreased oversight of the development of these physicians’ tools could have important implications for anatomic pathology groups and clinical laboratories.
Physician decision-support software utilizes medical laboratory test data as a significant part of a full dataset used to guide caregivers. Thus, if the FDA makes it easier for developers to get regulatory clearance for these types of products, that could positively impact medical labs’ ability to service their client physicians.
Additionally, clinical pathologists have unique training in diagnosing diseases and understanding the capabilities and limitations of medical laboratory tests in supporting how physicians diagnose disease and make treatment decisions. Thus, actions by the FDA to make it easier for developers of software algorithms that can incorporate clinical laboratory data and anatomic pathology images with the goal of improving diagnoses, decisions to treat, and monitoring of patients have the potential to bring great benefit to the nation’s medical laboratories.
FDA Clarifies Role in Regulating CDS/PDS Applications
The new guidelines clarified items specified in the 21st Century Cures Act, which was enacted by Congress in December of 2016. This Act authorized $6.3 billion in funding for the discovery, development, and delivery of advanced, state-of-the art medical cures.
“Today, we’re announcing three new guidances—two draft and one final—that address, in part, important provisions of the 21st Century Cures Act, that offer additional clarity about where the FDA sees its role in digital health, and importantly, where we don’t see a need for FDA involvement,” FDA commissioner Scott Gottlieb, MD, Commissioner of Food and Drugs, noted in a statement. “We’ve taken the instructions Congress gave us under the Cures Act and [we] are building on these provisions to make sure that we’re adopting the full spirit of the goals we were entrusted with by Congress.”
Helping Doctors’ Decision-Making
The first guideline concerns clinical decision support systems that are designed to help doctors make data-driven decisions about patient care. The new guidelines make it easier for software developers to get regulatory clearance, which, the FDA hopes, will spark innovation and makes regulation more efficient.
“CDS has many uses, including helping providers, and ultimately patients, identify the most appropriate treatment plan for their disease or condition,” Gottlieb said in the FDA’s statement. “For example, such software can include programs that compare patient-specific signs, symptoms, or results with available clinical guidelines to recommend diagnostic tests, investigations or therapy.
“This type of technology has the potential to enable providers and patients to fully leverage digital tools to improve decision making,” Gottlieb continued. “We want to encourage developers to create, adapt, and expand the functionalities of their software to aid providers in diagnosing and treating old and new medical maladies.”
Identifying Digital Health Applications That Receive/Don’t Receive FDA Oversight
The second guideline discusses and delineates which digital health applications are considered low risk and, thus, will not fall under FDA regulations.
Products that are not intended to be used for the diagnosis, cure, mitigation, prevention, or treatment of a condition will not be regulated by the FDA. These technologies are not considered medical devices and may include gadgets such as weight management and mindfulness tools. They can provide value to consumers and the healthcare industry while posing a low risk to patients.
“Similarly, the CDS draft guidance also proposes to not enforce regulatory requirements for lower-risk decision support software that’s intended to be used by patients or caregivers—known as patient-decision-support software (PDS)—when such software allows a patient or a caregiver to independently review the basis of the treatment recommendation,” Gottlieb noted in the statement.
Scott Gottlieb, MD (above), FDA Commissioner of Food and Drugs, noted in a statement, “We believe our proposals for regulating CDS and PDS not only fulfill the provisions of the Cures Act, but also strike the right balance between ensuring patient safety and promoting innovation. Clinical laboratories may find opportunities to work with CDS/PDS developers and support their client physicians. (Photo copyright: FDA.)
However, products that are intended to be used for the diagnosis, cure, mitigation, prevention, or treatment of a condition are considered medical devices and will fall under FDA regulations.
“The FDA will continue to enforce oversight of software programs that are intended to process or analyze medical images, signals from in vitro diagnostic devices, or patterns acquired from a processor like an electrocardiogram that use analytical functionalities to make treatment recommendations, as these remain medical devices under the Cures Act,” noted Gottlieb.
Items such as mobile apps that are utilized to maintain and encourage a healthy lifestyle are not deemed to be medical devices and will fall outside FDA regulations. The guidelines also defined that Office of the National Coordinator for Health Information Technology (ONC)-certified electronic health record (EHR) systems are not medical devices and, thus, will not be regulated by the FDA.
Software-as-a-Medical Device Gets FDA Oversight
The third guidance document deals with the assessment of the safety, performance, and effectiveness of Software as a Medical Device (SaMD).
“This final guidance provides globally recognized principles for analyzing and assessing SaMD, based on the overall risk of the product. The agency’s adoption of these principles provides us with an initial framework when further developing our own specific regulatory approaches and expectations for regulatory oversight and is another important piece in our overarching policy framework for digital health,” Gottlieb noted in the statement.
SaMD is defined by the International Medical Device Regulators Forum (IMDRF) as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”
Gottlieb noted that the three important guidance documents being issued would continue to expand the FDA’s efforts to encourage innovation in the ever-changing field of digital health. “Our aim is to provide more clarity on, and innovative changes to, our risk-based approach to digital health products, so that innovators know where they stand relative to the FDA’s regulatory framework. Our interpretation of the Cures Act is creating a bright line to define those areas where we do not require premarket review,” he concluded.
What remains to be seen is how the new FDA regulations will impact clinical laboratories and anatomic pathology groups. With the expanding interest in artificial intelligence (AI) and self-learning software systems, healthcare futurists are predicting a rosy future for informatics products that incorporate these technologies. Hopefully, with these new guidelines in place, innovative clinical laboratories will have the opportunity to develop new digital products for their clients.
—JP Schlingman
Related Information:
FDA Softens Stance on Clinical-decision Support Software
Clinical and Patient Decision Support Software
FDA Issues New Guidance for Clinical and Patient Decision Support Software
Statement from FDA Commissioner Scott Gottlieb, M.D., on Advancing New Digital Health Policies to Encourage Innovation, Bring Efficiency and Modernization to Regulation
FDA Issues Three Guidances, Including Long-awaited CDS Guidelines
The Feds Just Cleared a Major Roadblock for Digital Health
FDA Unveils Clinical Decision Support, Medical Device Guidance
Apr 4, 2018 | Laboratory Hiring & Human Resources, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
Clinical laboratories may want to offset plunging patient lab specimens by increasing outreach business
Hospital admissions are in decline across the country and the trend is being blamed in part on the rising use of high-deductible health plans (HDHP). The implications for hospital-based clinical laboratories is that lower in-patient totals reduce the flow of patient lab specimens as well. This situation may encourage some hospital and health-system labs to increase their lab outreach business as a way to offset declining inpatient lab test volumes and help keep down overall average test costs.
Healthcare Dive, which named “changing patient admissions” its “Disruptor of the Year,” used data from America’s Health Insurance Plans (AHIP) annual surveys to show the admission rate trend that is causing hospital operators and health systems to rethink how they do business going forward.
“We are really talking about how providers are not taking in as much revenue as they are spending,” Healthcare Dive noted. “Hospitals are largely fixed cost businesses, and rising expenses have been outpacing admissions growth.”
Experts Claim the ‘Hand Writing Is on the Wall’
According to Healthcare Dive’s analysis of US hospital admissions, which used data from the American Hospital Association’s Annual Survey, hospital admissions peaked at 35.4 million in 2013, coinciding with the roll out of the Affordable Care Act. The total fell to 34.9 million in 2014, before rebounding slightly to 35.1 million in 2015. The 2016 survey, published in 2018, showed hospital admissions remaining relatively flat at approximately 35.2 million.
Paul Hughes-Cromwick (above), Co-Director, Sustainable Health Spending Strategies, Altarum in Ann Arbor, Mich., expects hospitals to be challenged by flat admission rates going forward. “Times are still pretty good, but the writing is on the wall for hospital operators,” he told Modern Healthcare. This will impact clinical laboratories owned by hospitals and health systems as well. Photo copyright: Long Beach Business Journal.)
Most experts place the blame for slumping patient admissions on HDHPs. Such plans, which are paired with a tax-advantaged health savings account, have enabled employers to shift initial medical costs to workers in exchange for lower monthly health insurance premiums. Nearly 20.2 million Americans were enrolled in HDHPs in 2016, up from 15.4 million in 2013 and far above the roughly one million plans in existence in 2005, the AHIP surveys revealed. HDHPs were first authorized by Congress in 2003.
Consumers Delaying or Opting Out of Healthcare
Faced with higher out-of-pocket medical costs, consumers are opting to postpone or forgo elective surgeries and procedures, which in turn is placing pressure on healthcare systems’ operating revenues.
According to Healthcare Dive, Community Health Systems experienced a 12% drop in operating revenue in the first nine months of fiscal year 2017, while HCA Healthcare and Tenet Healthcare dropped 6.7% and 3.8%, respectively.
J. Eric Evans, President of Hospital Operations, Tenet Healthcare (NYSE:THC), a 77-hospital chain, told Modern Healthcare, today’s consumers are spending their healthcare dollars differently.
“The more elective procedures, things like orthopedics, we see the softness,” Evans told Modern Healthcare. “So, we think that does play into the story of deductibles rising and changing behaviors.”
The challenges for not-for-profit hospital systems are no different. Modern Healthcare noted that the 14-hospital Indiana University Health system reported a 46% drop in operating income in the third quarter of FY 2017 on a year-over-year admission decline of 2%.
Healthcare Systems Rethinking Their Business Strategies
“Health systems en masse are reacting to shifting dynamics in healthcare utilization by throwing money and resources to lower cost settings, such as urgent care centers and freestanding emergency departments,” Healthcare Dive noted. Dark Daily has reported on this trend. (See, “From Micro-hospitals to Mobile ERs: New Models of Healthcare Create Challenges and Opportunities for Pathologists and Medical Laboratories,” May 26, 2017.) Health systems also are selling unprofitable hospitals and laying off or eliminating positions to cut costs. Tenet Healthcare, for example, is laying off 2,000 workers while selling eight of its US hospitals and all of its nine United Kingdom facilities, Modern Healthcare reported in January.
“We are seeing and are working with health systems to take out pretty significant amounts of cost out of their operations, both clinical and nonclinical, and setting targets like 15-20%, which is a transformative change,” Igor Belokrinitsky, Vice President and Partner at Strategy&, PricewaterhouseCoopers’ strategy consulting group, told Healthcare Dive in a 2017 interview.
Lower hospital in-patient volume means less clinical laboratory test orders. This, in turn, will result in increases in the average cost per inpatient test. Anatomic pathology groups and medical laboratory leaders who work in or service hospitals may wish to take proactive steps to boost test referrals from outpatient and outreach settings as a way to help keep down the lab’s average cost per test.
—Andrea Downing Peck
Related Information:
Disrupter of the Year: Softening Patient Admissions
Hospital Volumes Laid Low by High-Deductible Health Plans
How Hospitals Feel about AHCA’s Death, Future with ACA
2016 Survey of Health Savings Account-High Deductible Health Plans
Fast Facts on U.S. Hospitals, 2018
5 Things to Know about Tenet Healthcare’s Restructuring
From Micro-hospitals to Mobile ERs: New Models of Healthcare Create Challenges and Opportunities for Pathologists and Medical Laboratories
Apr 2, 2018 | Digital Pathology, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
Ever shrinking “lab-on-a-…” technologies, a boon to medical laboratories and anatomic pathologists in remote resource-strapped regions, also have a place in modern labs
Researchers took another leap forward in reducing the size of clinical laboratory diagnostic tests and observational tools. This demonstration involved lab-on-a-fiber technology and showed promise in both monitoring anatomic pathology biomarkers in vivo and supplementing the abilities of existing lab-on-a-chip and microfluidic devices.
Lab-on-a-Fiber Next Technological Step Toward Miniaturization
In 2013, Dark Daily reported on research into an implantable laboratory-on-a-chip (LOC) for monitoring blood chemistry during chemotherapy. It was a major breakthrough at the time, which promised new and powerful tools for cancer treatment regimens.
However, most LOC systems aren’t designed for wet environments. Also, while microfluidics and flexible membranes allow for smaller footprints and tighter placement, they are still invasive in ways that might make patients uncomfortable or make real-world use less than ideal. And, long-term use brings further complications, such as corrosion or foreign-body granulomas.
Thus, lab-on-a-fiber’s ability to function in vivo, is one of the device’s principal advantages, as ExtremeTech noted.
Lab-on-a-fiber technology addresses many concerns. It is small enough to insert directly into organs, muscle mass, or veins when used as biosensors. And the fibers can return a wealth of information by using light and reflection, while allowing for minimal discomfort and precision placement.
Schematic of the lab-on-a-fiber biosensing principle. A metallic nanostructure supporting a resonant plasmonic mode is integrated on the optical fiber tip. When a molecular binding event occurs at the sensor surface, the reflectance peak associated to the plasmonic mode shifts towards longer wavelengths. (Image and caption copyright: Analyst/The Royal Society of Chemistry.)
The Past and Future of Scaling Clinical Laboratory Testing
Dark Daily has followed these miniaturization trends for years starting with their earliest stages. A detailed timeline of developments can be viewed in “Lab-on-a-Chip Diagnostics: When Will Clinical Laboratories See the Revolution?” from 2016.
Additional Dark Daily “lab-on-a-…” coverage includes:
- IBM Watson Health and Mount Sinai Health System team up to use LOC solutions to separate biomolecules as small as 20nm from samples (See Dark Daily, “IBM and Mount Sinai Researchers Develop Innovative Medical Lab-on-a-Chip Solution,” October 3, 2016); and,
- Lab-on-Skin devices for monitoring biomarkers and electrophysiological signals, providing human-machine interfaces, and facilitating optogenetics (See Dark Daily, “In the Field of Nano-Scale Diagnostics, Many Researchers Are Developing ‘Lab-on-Skin’ Technologies That Can Monitor Many Clinical Laboratory Biomarkers,” January 15, 2015).
In the past year, a myriad of lab-on-a-fiber applications also have received media coverage, including:
Developers believe lab-on-a-fiber approaches could offer further adaptability and functionality to other “lab-on-a-…” technologies. For example, as highlighted in Advanced Science News, researchers are employing lab-on-a-fiber technologies to further refine and improve LOC functions and designs.
“As the scientific world moves inexorably to smaller dimensions … The emerging concept of ‘lab‐on‐fiber’ will give the optical fiber platform additional (highly integrated) functionalities,” noted Deepak Uttamchandani, PhD, Vice Dean Research, Faculty of Engineering, and, Robert Blue, PhD, Research Fellow, both at the University of Strathclyde, Glasgow, UK, in their review paper, “Recent Advances In Optical Fiber Devices for Microfluidics Integration.” The paper, published in the Journal of Biophotonics, examined “the recent emergence of miniaturized optical fiber-based sensing and actuating devices that have been successfully integrated into fluidic microchannels that are part of microfluidic and lab‐on‐chip systems.”
In his review paper on the emerging concept of lab-on-a-fiber, Deepak Uttamchandani, PhD, notes, “The versatility of the optical fiber platform has already allowed researchers to conduct immunoassays in microchannels using both fluorescently‐labelled and label‐free formats whilst gaining advantages of reduced assay time and increased sensitivity.” (Photo copyright: University of Strathclyde.)
Lab-on-a-Fiber: Another Step Forward or a Major Change?
At each milestone in the scaling of clinical laboratory testing, experts and media outlets predicted the demise of big laboratories and the dawn of a POC-centric testing era. Yet, despite 20-plus years of progress, this has yet to happen.
While it is critical for anatomical pathology leaders and clinical laboratory managers to stay abreast of developments in testing technology, much of the innovation behind lab-on-a-fiber remains strictly in the research realm. Challenges to the commercialization of these new techniques include both physical factors, such as design and manufacture of ready-to-use tests, and regulatory concerns, including FDA clearances and payer approval of new assays and diagnostic procedures.
Until researchers and test manufacturers overcome these hurdles, threats to current standards and workflows are minimal. However, much like the gains in scale realized through incorporating lab-on-a-chip concepts into clinical laboratory testing, the research powering these innovations might prove useful in further improving and expanding medical laboratory testing options.
—Jon Stone
Related Information:
Optical Fiber Devices for Microfluidics Integration Open Up New Horizons for Advanced “Lab-on-a-Chip” Technologies
Recent Advances in Optical Fiber Devices for Microfluidics Integration
Lab-on-Fiber Technology: A New Vision for Chemical and Biological Sensing [Abstract]
Lab-on-Fiber Technology: A New Vision for Chemical and Biological Sensing [Full Downloadable PDF]
How We’re Shrinking Chemical Labs onto Optical Fibers
Lab-on-Fiber Could Shine Light on Disease
Doctors Might Soon Diagnose You by Feeding a Lab-on-a-Fiber Straight into Your Veins
Fiber-Optic Device Can Detect Stray Cancer Cells and Improve Tumor Removal: Study
Fiber Optic Probe Beats a Biopsy for Measuring Muscle Health
Lab-on-a-Chip Diagnostics: When Will Clinical Laboratories See the Revolution?
Implantable Medical Laboratory-on-a-Chip Continuously Monitors Key Chemicals in Chemotherapy and High-Risk Patients
In the Field of Nano-Scale Diagnostics, Many Researchers Are Developing ‘Lab-on-Skin’ Technologies That Can Monitor Many Clinical Laboratory Biomarkers
Hematology on a Chip: University of Southampton Develops POC Blood Analysis
Sleek ‘Lab in a Needle’ Is an All-in-One Device That Detects Liver Toxicity in Minutes during a Study, Showing Potential to Supplant Some Medical Laboratory Tests
Whole Animal Assays Use Lab-on-a-Chip at MIT
IBM and Mount Sinai Researchers Develop Innovative Medical Lab-on-a-Chip Solution
In the Field of Nano-Scale Diagnostics, Many Researchers Are Developing ‘Lab-on-Skin’ Technologies That Can Monitor Many Clinical Laboratory Biomarkers
Mar 30, 2018 | Compliance, Legal, and Malpractice, Digital Pathology, Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Developers believe participants will be interested in controlling how their private health data is provided to medical laboratories, drug companies, research organizations, and the federal government, while also earning an income
Bitcoins for blood tests, anyone? A new venture is examining the idea of exchanging cryptocurrency, a digital asset, for the results of weekly clinical laboratory tests and photographs of body parts from healthcare consumers. If successful, in a couple of years, people might be able to earn a “basic income” from selling their private health data to pharmaceutical companies, medical laboratories, research organizations, the federal government, and more.
Insilico Medicine, a Baltimore developer of artificial intelligence (AI) solutions for research and pharmaceutical companies, and the Bitfury Group, a blockchain technology company based in Amsterdam, Holland, are working together on the project they call Longenesis, a blockchain-based platform that uses AI to collect, store, manage, and trade data, such as medical records and health data.
Marketing Human Life Data
The two participants presented their novel idea this past November in Taipei, Taiwan, at the TaiwanChain Blockchain Summit. They published their report in Oncotarget, an open-access biomedical journal that covers oncology research. The authors of the paper believe blockchain and AI technologies could support patients and physicians in working with medical data.
“There are many companies engaged in the marketplaces of human life data with billions of dollars in turnover. However, the advances in AI and blockchain allow returning the control of this data back to the individual and make this data useful in the many new ways,” Alex Zhavoronkov, PhD, founder of Insilico Medicine, told Cryptovest.
“I would love to live in a world where I’m motivated to regularly take all kinds of medical tests for free, I get the data back, and I will be able to sell this data to the marketplace, and I earn all kinds of goods and services—primarily health related,” Zhavoronkov told Motherboard.
Alexander Zhavoronkov, PhD, Founder and CEO of Insilico Medicine, told Motherboard, “Right now, it’s difficult to predict. But I think that if [users] submit blood tests, pictures, transcriptomes let’s say on a weekly basis, you probably will be able to earn a good universal basic income.” Zhavoronkov is describing a new business model involving clinical laboratory testing. (Photo copyright: Insilico Medicine.)
Combining blockchain and AI technologies is one of the many emerging technological advances emerging to enhance the medical and pharmaceutical industries.
“Recent advances in machine intelligence turned almost every data into health data. The many data types can now be combined in the new ways: one data type can be inferred from another data type and systems learning to optimize the lifestyle for the desired health trajectory can now be developed using the very basic and abundant data,” noted Polina Mamoshina, research scientist at Pharma AI, a division of Insilico Medicine, during the company’s presentation at TaiwanChain. “Pollen, weather, and other data about the environment can now be combined with the human biomarkers to uncover and minimize the allergic response among the myriad of examples. People should be able to take control over this data.”
Because pharmaceutical companies rely on data mining to obtain individual demographic information and medical records, the growth potential for this type of product is huge.
Clinical Laboratory Test Results Earn LifePound Tokens
Longenesis is still being tested, but Zhavoronkov hopes it will be ready for the public within the next two years. The plan is to utilize blockchain technology to collect and store patient medical data in exchange for their cryptocurrency, known as LifePound.
According to the Longenesis website, “Longenesis is a marketplace, which uses personal health data, transformed into a LifePound token. LifePound is used inside a marketplace as a monetary system, powered by Exonum blockchain technology to keep data secure and transparent. Tokens are distributed between Longenesis marketplace members and are used for transactions between the following elements:
- Developers;
- Users;
- Data providers;
- Customers; and the,
- Stock cryptocurrency market.
The developers believe the “Longenesis Data Marketplace will be able to provide new insights in the fields of healthcare research and development. It will provide analysis and recommendations to pharmaceutical companies to help develop new drugs.”
It’s too early to predict whether Longenesis will be successful and catch on with the public. However, the popularity of cryptocurrency, and the opportunity to earn an income from one’s clinical laboratory data, could encourage individuals to participate in this type of endeavor.
In addition, this is a highly unusual and unexpected approach to encourage consumers to undergo regular medical laboratory testing in order to earn payment by a digital currency. It is a reminder of how rapid advances in a myriad of technologies are going to make it possible for entrepreneurs to create new business models that involve clinical laboratory tests and the data produced by such tests.
—JP Schlingman
Related Information:
This Biotech Company Wants You to Give It Selfies and Blood Tests in Exchange for Cryptocurrency
A Decentralized Medical Record Marketplace Powered by Human Data
Blockchain, AI Could Spur Biomedical Research, Insilico Medicine Says
Converging Blockchain and Next-generation Artificial Intelligence Technologies to Decentralize and Accelerate Biomedical Research and Healthcare
Blockchain, Explained
Mar 28, 2018 | Laboratory Hiring & Human Resources, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Microhospitals already offer most of the critical features of traditional hospitals, and by featuring telemedicine technology at the point of care, they are becoming powerful tools for healthcare providers
Dark Daily reported in January that microhospitals are opening nationwide, including in such innovative states as Texas, Colorado, Nevada, and Arizona. In addition to being open 24/7 and mostly located in high-density areas, these scaled down hospitals feature the most critical aspects of full-size hospitals—medical laboratories, emergency departments, pharmacies, and imaging centers.
However, a report by the Health Resources and Service Administration (HRSA) predicted that by 2020 the US will be short as many as 20,000 primary care physicians! Many specialty practices also are expected to see stiff shortages of physicians in the near future. Without enough physicians, even microhospitals cannot provide adequate care.
Thus, the ever increasing practice of using telemedicine as a way to serve more people, while providing faster, more efficient care tailored to meet the needs of individuals and communities, is welcomed news. If this trend becomes more widespread, it will create new opportunities and challenges for clinical laboratories in hospitals, as well as health systems that own and operate microhospitals.
Filling a Need in Vulnerable Communities
At the end of 2016, there were approximately 50 microhospitals operating in the United States, mostly in the Midwest, Arizona, Colorado, Nevada, and Texas. Sometimes referred to as neighborhood or community hospitals, microhospitals are acute care facilities that are smaller than traditional hospitals but can deliver many of the same medical services. They provide more comprehensive treatments than typical urgent care and outpatient centers and fill a gap between freestanding healthcare centers and major hospitals.
Microhospitals typically have less than a dozen short-stay beds and have the ability to provide inpatient care, emergency care, and imaging and medical laboratory services. And, they are usually affiliated with larger healthcare systems, which allows them to expand into certain areas without incurring the high costs of building a full-scale hospital.
“Right now they seem to be popping up in large urban and suburban metro areas,” Priya Bathija, Vice President, Value Initiative American Hospital Association, told NPR. “We really think they have the potential to help in vulnerable communities that have a lack of access.”
Patient Satisfaction and Declining Physician Populations Drive Demand for Telemedicine
Telemedicine, a combination of telecommunications and information technology, is primarily used to remotely connect healthcare providers to patients during office visits. But it also is being used successfully at the point of care in emergency departments and even surgery.
Microhospitals like St. Vincent Neighborhood hospital in Noblesville, Ind., which offer most of the critical functions of traditional hospitals, such as clinical laboratories, ERs, and the CT scanning station above (left), are increasingly including telemedicine technologies (above right) at the point of care to offset reductions in primary care and specialty physicians. (Photo copyright: Jill Sheridan/IPB News.)
Consumers are becoming more accepting of telemedicine (AKA, telehealth) as these services offer savings in both time and money. A recent survey by the Health Industry Distributors Association (HIDA) found that many patients were pleased with telehealth services. More than 50% of the surveyed individuals stated they were very satisfied with a recent telemedicine encounter. In addition, 54% of those individuals described their telehealth experience as better than a traditional, in-person office visit.
Telemedicine and Microhospitals Mutually Beneficial, According to HRSA
Other research suggests microhospitals may generate a mutually beneficial alliance with telemedicine that increases the progress of both entities, especially when considering projected increases in the number of nurse practitioners and physician assistants.
In its report, “Projecting the Supply and Demand for Primary Care Practitioners Through 2020,” Health Resources and Service Administration (HRSA) estimates there will be a shortage of more than 20,000 primary care physicians working in the US by the year 2020. Other specialties expected to experience staff shortfalls include:
Anticipation of this decline in physician numbers is fueling the demand for telemedicine to help with patient loads, especially in remote areas.
Saving Time and Money with Televisits
A study by Nemours Children’s Health System indicates that telemedicine may reduce medical costs for both patients and healthcare providers while sustaining patient satisfaction.
“At Nemours, we’ve seen how telemedicine can positively impact patients’ lives,” Shayan Vyas, MD, Medical Director of Telehealth at Nemours, noted in a press release. “The overwhelmingly positive response we’ve seen from parents who are early adopters of telemedicine really reinforces the feasibility of online doctor visits and sets the stage for real change in the way healthcare is delivered.”
The Nemours study involved 120 patients under the age of 18. The majority of families surveyed stated they would be interested in future telehealth visits and an impressive 99% said they would recommend telemedicine to other families.
The study discovered that patients and family members saved an average of $50 and about an hour of time, by utilizing telehealth for sports medicine appointments. The health system also experienced some monetary perks with the televisits, as they cost approximately $24 less per patient.
“We know that telemedicine is often looked to for common childhood ailments, like cold and flu, or skin rashes. But we wanted to look at how telemedicine could benefit patients within a particular specialty such as sports medicine,” Alfred Atanda Jr, MD, Pediatric Orthopedic Surgeon at Nemours/Alfred I. DuPont Hospital for Children in Wilmington, DE., told FierceHealthcare. “As the healthcare landscape continues to evolve and the emphasis on value and satisfaction continues to grow, telemedicine may be utilized by providers as a mechanism to keep costs and resource utilization low, and to comply with payer requirements.”
Healthcare consumers and providers are increasing looking to technology to enhance medical care and solve resource shortfalls. Separately, telehealth and microhospitals already help with these needs, Combined, however, they are a powerful solution to our nation’s reducing ranks of primary care physicians and medical specialists.
If this trend of microhospitals using telemedicine should continue and increase, both components will give medical professionals vital tools to provide faster, more economical, and more personalized services, to more patients across wider areas of America.
—JP Schlingman
Related Information:
Why Telehealth is Fueling the Move Towards Microhospitals
Projecting the Supply and Demand for Primary Care Practitioners Through 2020
Are Microhospitals the Answer for Systems Looking for Low-cost Expansions? They Might Be
Microhospitals: Healthcare’s Newest Patient Access Point
Microhospitals Could Prove Financial Boon and Salvation to Healthcare Systems
Microhospitals Provide Health Care Closer to Home
Telemedicine Saves Patients Time and Money, Study Shows
5 Common Questions about Micro-Hospitals, Answered
Survey: More than Half of Patients Prefer Telehealth Visits to In-Person Care
Majority of Parents Plan to Use Telemedicine for Pediatric Care
Microhospitals May Help Deliver Care in Underserved Areas
“Thinking Small” May Be Next Big Innovation in Healthcare Delivery as Microhospitals Spring Up in Metropolitan Areas Across Multiple States
