Washington State has passed a law that will curtail the flow of consumer health data, notably affecting tech companies and advertisers.

The My Health, My Data Act, signed by Gov. Jay Inslee last week, requires companies to get “unambiguous” consent before they collect health data, which includes everything from health conditions to location information associated with health services. Most of the law takes effect in March 2024.

“This could really, in a way, reset the conversation on privacy, at least as it’s developing at the state level,” according to Keir Lamont, director of the US legislation team at the think tank Future of Privacy Forum, which submitted notes on a prior version of the bill.

The law comes as state and federal legislators seem increasingly interested in privacy laws aimed at the largely unregulated industries of data collection and (*cough, cough*) digital advertising. For some, the Supreme Court’s decision to overturn Roe v. Wade has added to the urgency.

In the absence of a national privacy law, the Federal Trade Commission has taken action against companies it claims have collected and shared sensitive health information, like location data associated with medical care or reproductive health, or customer health data shared via common advertising tools like tracking pixels.

“With the recent Dobbs decision, with the restriction of access to reproductive healthcare in other states…it became evident that women’s health data needed to be protected—that people who were accessing reproductive care, gender-affirming care, and were seeking it in Washington State needed to be protected,” Washington State Rep. Vandana Slatter, who introduced the bill, told Marketing Brew. “There was a gap in that protection on websites, apps, and searches.”

The Washington State law aims to close the gaps in one of the few federal privacy laws, the Health Insurance Portability and Accountability Act (HIPAA).

Keep reading at Marketing Brew.—RB

Did you know that 100k knee replacement surgeries fail every year? What’s more, 50% of revision surgeries are related to instability, malalignment, or malposition.

But change is potentially coming to this $19.4b market. The two founders of Monogram Orthopedics recently made history in this industry with the first fully remote, simulated robotic surgery.

Meet Monogram, the company working to bring surgical robots into the operating room. Monogram has developed customized joint implants using 3D printing and high-accuracy surgical robots with the goal of improving surgical outcomes and reducing patient downtimes.

With FDA approval for their implant components under their belt, Monogram is working toward the introduction of their robotic knee replacement system to the operating room and have already held successful surgical demonstrations using their technology.

Invest in Monogram before their planned Nasdaq listing—their current round closes on May 10.

Whether it’s a tongue depressor or an X-ray machine, all medical devices have to first go through the FDA to ensure they’re safe for patient use. But not every device can receive FDA approval.

The FDA uses a risk-based classification to determine whether to grant clearance or approval to medical devices. The higher the classification, the more regulatory controls are required to ensure the device’s effectiveness and safety.

Class I devices present the lowest risk, and are usually exempt from many statutory and regulatory review requirements, even though device manufacturers must register with the FDA and list their devices with the agency.

This class includes products like dental floss; it’s not likely that “there’s going to be a risk of harm,” Benjamin Zegarelli, an attorney who advises clients on FDA regulations at Mintz law firm, told Healthcare Brew.

Class II devices exhibit moderate risk and are the largest class of devices the FDA reviews, according to Zegarelli. These devices require specific controls to ensure their safety, such as “performance standards, postmarket surveillance, [or] patient registries,” according to a Congressional Research Service report.

The FDA, for example, recommends special controls such as stability testing to determine the shelf life of electrocardiograph electrodes, the small patches that attach to the skin to measure the heart’s electrical activity.

Class III devices have the highest associated risks and include life-sustaining devices or implants, Zegarelli said. However, this category also includes novel devices that the FDA has never seen before.

“The reasoning being that the FDA doesn’t know what it is [and] doesn’t have experience with the special controls required,” Zegarelli said.

Keep reading here.—KW

Do you work in healthcare or have information about the industry that we should know? Email Kristine at [email protected]. For completely confidential conversations, ask Kristine for her number on Signal.

It wasn’t long after Devika Mathrani joined NewYork-Presbyterian in July 2021 that she decided the health system’s old brand needed to go.

“I think it was the first week of August that I had a conversation with my incredible CEO, Dr. [Steven J.] Corwin,” Mathrani, NewYork-Presbyterian’s chief marketing and communications officer, recalled. “I said, I think I need to blow up the brand a bit.”

At the time of Mathrani’s arrival, NewYork-Presbyterian was using the tagline “Amazing Things are Happening Here,” brand messaging that had been in place for years following the 1998 merger between The New York Hospital and The Presbyterian Hospital that created the new institution. The tagline and accompanying black-and-white documentary-style ads, in which patients talk about their experience with the health system, had been praised, yes—but it was past time for a change, Mathrani said.

“The reality was that the campaign and the message had gotten quite dated,” Mathrani told Marketing Brew. “It was all about the white coats and the nurses being amazing, but it didn’t really bring the consumer into the story.”

Mathrani got to work, looking to shift the brand’s messaging in a rapid four-month timeframe to focus more on everyday care, in partnership with Havas New York. “I want to be a partner in people’s preventative health journeys, not just this scary place where they go when they’re really, really sick,” she said.

By November 2021, NewYork-Presbyterian had a shorter, snappier brand borne from the old one: “Stay Amazing.” Mathrani felt it was particularly resonant “in a coming-out-of-Covid environment where people just needed some optimism.”

Keep reading at Marketing Brew.—KS

Today’s top healthcare reads.

Stat: Some protein bars have upward of 28 grams of sugar, “twice the amount in a Dunkin’ Donuts chocolate frosted doughnut with sprinkles.” (the New York Times)

Quote: “It’s a social injustice. You will never be totally well if you don’t have oral health.”—Adrienne Grimmett, director of dental services at Evara Health, on low-income people’s unequal access to care (Tampa Bay Times)

Read: Sudan’s healthcare system is on the brink of collapse. (the New York Times)

Catch up on the top Healthcare Brew stories you may have missed:

• Say goodbye to trypanophobia—this biotech is trying to turn injectable drugs into pills
• Jefferson Health uses AI to help diagnose patients
• NYC Health + Hospitals attracts behavioral health pros with student debt relief