Ariel Katz, H1

The biopharmaceutical and healthcare news of 2020 and much of 2021 has been dominated by Covid-19. The pandemic has been a driver and accelerator of dramatic changes that will shape the healthcare ecosystem in 2022 and beyond. The impact of Covid and other important trends and new legislation were widely discussed at this year’s MedTech Conference. Here are four that will have a major impact.

Patients demanded ownership of their healthcare data—and finally get it

In April 2021, the Interoperability, Information Blocking, and ONC Health IT Certification, went into effect. This rule requires that healthcare providers give patients access to their clinical information (e.g., consultation and treatment notes) without delay. By late 2022, those clinical notes must also be shared with patients’ health apps. While this might seem like a small change, it has a big impact on patients, who can now demand a copy of their healthcare record and are guaranteed to receive it in a timely manner.

In the past, it was the patient’s responsibility to ensure doctors had all their medical records. This put an enormous administrative burden on patients, who had to keep track of the information, chase down physical copies (e.g., x-ray images) and personally deliver them to healthcare providers (HCPs).

Apps can reduce this burden and the Cures Act now ensures that patients have unfettered access to their data and can easily share it with other HCPs (e.g., specialists, emergency doctors).

Patient data are better protected—and could start make patients money

The advantages and convenience of generating health data using electronic devices and health apps come at the price of privacy. While HIPAA privacy rules prohibit the disclosure of protected health information, it does not prohibit the commercialization of health data collected by fitness trackers, wearables and health apps. Currently, this data can be sold by the technology companies collecting it to health insurers, employers or third parties like Facebook without the consumer’s consent or knowledge.

At MedTech, Sen. Bill Cassidy (R-LA) discussed legislation that would enable patients to opt out of the selling/sharing of that data and not be left out of money shared during the exchange of their data. Similar legislation will give individuals control of the data they generate and usher in a wave of possibilities, not the least of which is the commoditization of that data.

Insurers have to provide accurate information about their physician network—or be fined

A recent study by The Centers for Medicare & Medicaid Services (CMS) found that almost 50% of providers listed in the directories of Medicare Advantage Organizations had at least one inaccuracy (e.g., wrong location or phone number) that can create barriers for members seeking services. As a consequence, CMS is now empowered to enforce hefty penalties for such errors, ensuring that patients experience fewer challenges in getting the care they need.

Clinical trials will be decentralized, longer—and more inclusive

Covid forced drug sponsors to change the way they undertake clinical studies; wearables helped with moving from in-person to in-home or remote reporting and also allowed extended tracking of patients to generate more meaningful and longer-term data. The trends toward decentralization of clinical trials and remote tracking are here to stay and will make it more feasible for underrepresented communities to enroll in clinical studies, adding much needed diversity.

Comprehensive databases support this trend by giving life science companies the tools they need to better plan clinical trials and expand their understanding of investigators and sites.

The common theme of these trends is easier access to more data will improve health outcomes for patients and help generate more meaningful data, but safeguards are necessary to protect patients’ sensitive health data.

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Four trends shaping healthcare in 2022 and beyond