A call for independent policing of non-HIPAA health data. The Center for Democracy & Technology, a nonprofit organization focused on tech policy and architecture, and the eHealth Initiative & Foundation, a coalition of industry and academic stakeholders, yesterday released a framework proposal calling for self-regulation of consumer data use by health devices and products that don’t legally require HIPAA compliance.
Under the framework, companies making these products would agree to a new set of standards that rely less on simply providing consumers with notice and consent, and instead place more emphasis on limiting which data is being collected while allowing consumers to request or delete their saved information. These standards would be handled by a group that could be funded by annual fees from participating entities but would otherwise have no conflicts of interest. The program itself would include annual audits and compliance assessments, random spot checks, public commitments to follow the standards, an active complaint-gathering process, potential FTC or state attorney general enforcement of violations, and more.
Add another SPAC to the list. Sema4, a well-funded Mount Sinai spinout building genomic and clinical data analytics platforms, today announced its plans to merge with special purpose acquisition company (SPAC) CM Life Sciences.
The companies said the deal will bring a total of $793 million in cash to the company and its shareholders (who will receive up to $343 million). The deal values Sema4 at about $2 billion, and will help the company continue to grow as it looks to deliver its offerings to more providers and patients.
“This transaction is a significant milestone for Sema4,” said Eric Schadt, PhD, founder and CEO of Sema4. “The additional resources will allow us to greatly accelerate our business plans organically and inorganically, developing and bringing in more cutting-edge precision model solutions across multiple disease areas. This is the most exciting time in the history of our industry and I look forward to working closely with Eli [Casdin], Keith [Meister], and their teams to deliver on the massive potential to transform clinical and life sciences through better leveraging of data.”
Smartphone PPG on par with medical devices. A study recently published in Chest lends additional support to smartphone-powered photoplethysmography (PPG) for remote monitoring of patients’ pulse oximetry.
To explore the method already employed by a handful of consumer health products (for instance, Google), researchers had 10 volunteers of Caucasian, Black and Asian ethnicities scan their finger using the smartphone and an optical data analysis app called the MaximFast app. They breathed gas mixtures to alter their arterial oxygen saturation and found that the blood oxygen measurements were on par with other FDA-approved tools.
As a follow-up, they also conducted an open-label study on 2,200 readings taken from 320 participants of varying backgrounds in which smartphone and hospital reference device readings were collected simultaneously, and found their performance to be similar.
Localizing digital mental health support. Happify Health announced this week that it has expanded the language support for its digital mental health program platform. Castilian Spanish and Italian are the newest additions, bringing the total number of offered languages to 10. The company notes that the support tackles additional cultural and localization concerns such as regional-specific images, pop culture references and regional accents.
“Our top priority is for our users to feel that our content is relevant and relatable – incorporating the nuances of their language and culture – so they can get the most out of their experience,” Tiffany Sun, chief content officer at Happify Health, said in a statement. “With each new language, our dedicated localization teams perform a comprehensive review before adapting the content for a specific audience, whether it’s a 28-day guided meditation track or an evidence-based game. We always aim to ensure that we’re offering a culturally appropriate experience while maintaining scientific fidelity.”